Acute Pulmonary EmbolismHOME-PE2NCT07506291
HOME-PE2 : Home Treatment Versus Hospitalization in Patients With Acute Pulmonary Embolism, no Clinical Severity Criteria, and Either Right Ventricular Dysfunction or Elevated Troponin: a Randomized Controlled Trial
A study testing Home treatment and Hospitalization in people with Acute Pulmonary Embolism, run by University Hospital, Angers at 18 sites in France.
Trial summary
This study (HOME-PE2) is a multicenter, randomized controlled trial comparing home treatment versus hospitalization in patients with acute pulmonary embolism (PE) who have no clinical severity criteria according to the Hestia rule but present either right ventricular dysfunction or elevated cardiac troponin levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- Home treatment and Hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 18 sitesFrance
- Study dates
- Jun 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presentation to the Emergency Department or unscheduled consultation in one of the participating centers
- Symptomatic PE objectively confirmed according to the European Society of Cardiology criteria 4 (either by i) a high-probability ventilation/perfusion lung scan, ii) a new contrast filling defect on spiral computed tomography, or iii) a new documentation by ultrasonography of a proximal DVT, i.e., thrombus in the popliteal vein or above, along with clinical signs of PE. All radiological tests used to diagnose PE will be interpreted by on-site radiologists or angiologists)
- No clinical criteria mandating hospitalization according to the Hestia rule, i.e., negative Hestia rule
- Right ventricular dysfunction - defined as a right ventricular (RV) to left ventricular (LV) diameter ratio > 1.0 on echocardiography (apical four-chamber or subcostal four-chamber view) or on CTPA (transverse plane) OR High-sensibility cardiac troponin I or T concentration above the upper limit of local normal value
- Insurance cover according to local legislation
- Age ≥18 years
- Signed free informed consent (or oral consent if possible according to local regulation).
Who cannot join
- Shock or hypotension (defined as systolic blood pressure <90 mmHg or a systolic pressure drop by ≥40 mmHg, for >15 minutes, if not caused by new-onset arrhythmia, hypovolemia, or sepsis)
- Combined right ventricular dysfunction (RV/LV > 1.0 on imaging) AND troponin concentration above the upper limit of local normal value
- Free floating thrombi in the right atrium or ventricle, if identified by routine echocardiography or CTPA
- Active cancer other than basal or squamous-cell skin cancer defined at least with one of the following: i) cancer diagnosed within the last 6 months, ii) current anti-cancer treatment or during the 6 months before enrollment, iii) locally advanced or metastatic cancer
- PE diagnosis established since more than 24 hours
- 48 hours or more elapsed between ED presentation and potential inclusion or other reason making home discharge impossible within the 48 hours since ED presentation
Show all 9Show fewer
- Limited life expectancy or any other reason making 3-month follow-up impossible
- Pregnant or parturient patient
- Patient in detention by judicial or administrative decision, under a legal protection measure or undergoing compulsory psychiatric treatment
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
France18 sites
Angers University Hospital, Emergency Department
Angers, 49000
Pierre-Marie ROY, Professor, +33 (0)2 41 35 37 18, PMRoy@chu-angers.fr
Argenteuil hospital, Emergency department
Argenteuil, 95100
Catherine Le Gall, Doctor, 0134232425, catherine.legall@ch-argenteuil.fr
Brest University Hospital (site Cavale Blanche), Cardiology Department
Brest, 29200
Francis COUTURAUD, Professor, +33 (0)2.98.34.73.47, francis.couturaud@chu-brest.fr
Cholet Hospital, Emergency department
Cholet, 49300
Caroline Soulie, Doctor, 0241496985, caroline.soulie-chavignon@ch-cholet.fr
Clermont-Ferrand University Hospital, Emergency department
Clermont-Ferrand, 63000
Jeannot SCHMIDT, Professor, +33 (0)4 73 75 45 49, jschmidt@chu-clermontferrand.fr
Paris University Hospital (APHP - site Louis Mourier), Emergency Department
Colombes
Nicolas JAVAUD, Professor, +33 (0)6 73 87 29 72, nicolas.javaud@aphp.fr
Grenoble University Hospital, Emergency Department
Grenoble, 38000
Damien Viglino, Professor, 0476766784, dviglino@chu-grenoble.fr
Le Mans Hospital, Emergency department
Le Mans, 72000
Cyrielle Houalard, Doctor, 0243434343, cyrielle.houalard@gmail.com
Lyon University Hospital (site Edouard Herriot), Emergency Department
Lyon, 69003
Antonin THIBIEROZ, Doctor, +33 (0)4.72.11.22.93, youri.yordanov@chu-lyon.fr
Nantes University Hospital, Emergency department
Nantes, 44000
François Javaudin, Doctor, 0240083333, Francois.JAVAUDIN@chu-nantes.fr
Paris University Hospital (APHP - site Lariboisière hospital), emergency department
Paris, 75010
Anthony Chauvin, Professor, +33 (0)149956565, anthony.chauvin@aphp.fr
Paris University Hospital (APHP - site La Pitié-Salpétrière Hospital), Emergency Department
Paris, 75013
Yonathan Freund, Doctor, +33 (0)1 42 16 00 00, yonathan.freund@aphp.fr
Paris University Hospital (APHP - site HEGP), Emergency Department
Paris, 75015
Richard Chocron, Professor, +33 (0)156095876, richard.chocron@aphp.fr
Paris University Hospital (APHP, site Hôpital Européen Georges Pompidou), Pneumology department
Paris
Olivier SANCHEZ, MD.PhD, +33 (0)1 56 09 34 87, olivier.sanchez@aphp.fr
Anne-Laure FERAL, MD, anne-laure.feral-pierssens@aphp.fr
Lyon University Hospital (site Lyon Sud), Emergency department
Pierre-Bénite, 69495
Marion Douplat, Doctor, +33 (0)478862854, marion.douplat@chu-lyon.fr
Poitiers University Hospital, Emergency Department
Poitiers, 86000
Nicolas Marjanovic, Doctor, +33 (0)5.49.44.44.44, nicolas.marjanovic@chu-poitiers.fr
Rouen University Hospital, Emergency Department
Rouen, 76000
Mélanie Roussel, Doctor, 0232881879, melanie.roussel@chu-rouen.fr
Toulouse University Hospital, Emergency Department
Toulouse, 31000
Felipe GUERRERO, Doctor, +33 (0)5 61 32 22 71, guerrero.f@chu-toulouse.fr
About this study
This study (HOME-PE2) is a multicenter, randomized controlled trial comparing home treatment versus hospitalization in patients with acute pulmonary embolism (PE) who have no clinical severity criteria according to the Hestia rule but present either right ventricular dysfunction or elevated cardiac troponin levels.
While outpatient management is considered safe for low-risk PE patients, the optimal management of patients without clinical severity but with signs of right ventricular strain or myocardial injury remains uncertain, and current guidelines are inconsistent. As a result, most of these patients are still hospitalized despite limited evidence supporting this approach.
Read more
The primary objective is to assess whether home treatment is non-inferior to hospitalization in terms of safety, defined by the 7-day rate of adverse events according to the EARTH consensus. Secondary objectives include evaluation of net clinical benefit, quality of life, functional status, and healthcare resource utilization, as well as exploration of sex-related differences and cost-effectiveness.
A total of 568 adult patients with confirmed PE will be randomized (1:1) to either home treatment with early discharge or standard hospitalization. Patients will be followed for 90 days.
Read the detailed description
PE is a common and potentially life-threatening condition with a wide spectrum of clinical severity. In recent years, outpatient management has been demonstrated to be safe and effective in selected low-risk patients, particularly those without hemodynamic instability or significant comorbidities. Risk stratification tools such as the Hestia rule are widely used to identify patients eligible for home treatment based on clinical criteria.
However, uncertainty remains regarding the optimal management of patients who, despite having no clinical severity criteria according to the Hestia rule, present signs of right ventricular dysfunction (RVD) on imaging or elevated cardiac troponin levels. These markers are associated with an increased risk of adverse outcomes in some populations and are used in certain guidelines to classify patients as intermediate risk, often leading to hospitalization. In contrast, other recommendations do not require systematic cardiac assessment in clinically stable patients and support outpatient care in the absence of clinical severity criteria. As a result, clinical practice remains heterogeneous, and hospitalization is still frequently preferred in this subgroup despite limited prospective evidence.
The HOME-PE2 study is designed to address this gap by comparing two commonly used management strategies-home treatment and hospitalization-in this specific population. The trial aims to determine whether outpatient management is non-inferior to hospitalization in terms of short-term safety, while also evaluating broader patient-centered and health system outcomes.
HOME-PE2 is an international, multicenter, open-label, randomized controlled trial with blinded adjudication of clinical outcomes. Eligible adult patients presenting to the emergency department with objectively confirmed acute PE will be assessed for clinical severity using the Hestia rule. Patients without clinical criteria requiring hospitalization but with either RVD on imaging or elevated cardiac troponin levels will be randomized in a 1:1 ratio to either home treatment or hospitalization. Randomization will be stratified by country and by the qualifying cardiac abnormality.
Patients allocated to the home treatment group will be discharged early after inclusion, according to predefined timelines consistent with outpatient management. Patients assigned to the hospitalization group will receive standard inpatient care according to local practice. In both groups, anticoagulant therapy will be initiated and managed according to current guidelines and local protocols.
The study incorporates pragmatic features, including the comparison of usual care management strategies and flexibility in anticoagulation treatment according to local practice, thereby enhancing the generalizability of the findings to real-world clinical settings.
All patients will receive structured follow-up over a 90-day period. Clinical follow-up will include scheduled assessments shortly after inclusion and at later time points, either through in-person visits aligned with routine care or via telephone contact. In addition, patient-reported outcomes will be collected longitudinally using validated instruments assessing health-related quality of life and functional status. Data on healthcare utilization, including hospital readmissions and length of stay, will also be collected.
An independent clinical events committee, blinded to treatment allocation, will adjudicate all suspected outcome events based on predefined criteria to ensure consistency and reliability of endpoint assessment.
Beyond safety, the study will evaluate the overall net clinical benefit of home treatment compared with hospitalization, integrating multiple clinically relevant outcomes in a hierarchical framework. It will also assess the impact of management strategy on patient-reported outcomes, including quality of life and functional recovery, as well as healthcare resource use.
In addition, exploratory analyses will examine the influence of sex and living conditions on outcomes, in order to better understand potential differences in the feasibility and impact of outpatient care. A health-economic evaluation will be conducted to compare cost-utility and to estimate the potential budget impact of implementing outpatient management strategies in this population.
By rigorously comparing home treatment and hospitalization in patients with acute PE without clinical severity but with cardiac involvement, the HOME-PE2 trial aims to generate high-quality evidence to inform clinical guidelines, improve patient-centered care, and optimize the use of healthcare resources.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- Home treatment, Hospitalization
- Keywords
- pulmonary embolism, Outpatient treatment, Home treatment, Hospitalization, Hestia rule, Right ventricular dysfunction, Troponin, Risk stratification, Randomized controlled trial, Quality of life, Functional status, Health economics
- Medical subject headings
- Pulmonary Embolism, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home treatmentOther
Outpatient management strategy for acute pulmonary embolism, including early discharge after diagnosis and initiation of anticoagulation therapy, with follow-up according to current guidelines and local practice.
HospitalizationOther
Inpatient management strategy for acute pulmonary embolism, including hospital admission and standard care with anticoagulation therapy according to current guidelines and local practice.
| Study group | Role | What they receive |
|---|---|---|
| Home treatment | Experimental | Patients randomized to this arm are managed as outpatients and discharged early after inclusion, no later than 24 hours after inclusion and no later than 48 hours after presentation to the emergency department. Anticoagulation therapy is initiated prior to discharge and continued in accordance with current guidelines and local practice. Patients receive structured follow-up in accordance with current guidelines and are instructed to seek medical attention in case of clinical deterioration, suspected recurrence of venous thromboembolism, or bleeding. Receives: Other: Home treatment |
| Hospitalization | Active comparator | Patients randomized to this arm are managed as inpatients and admitted to a hospital medical unit for the management of acute PE according to local organization. Anticoagulation therapy is initiated and managed in accordance with current guidelines and local practice. The duration of hospitalization and timing of discharge are left to the discretion of the treating physician. Patients receive structured follow-up in accordance with current guidelines and are instructed to seek medical attention in case of clinical deterioration, suspected recurrence of venous thromboembolism, or bleeding. Receives: Other: Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day composite incidence of adverse events (EARTH criteria)
Composite outcome defined according to the EARTH consensus, including the occurrence of any of the following events within 7 days after randomization: death possibly or confirmed to be related to pulmonary embolism (including death of undetermined cause), hemodynamic failure, respiratory failure, cardiac rhythm disorders requiring urgent treatment, major bleeding (according to ISTH definition), or recurrent venous thromboembolism (symptomatic pulmonary embolism or proximal deep vein thrombosis requiring treatment or modification of anticoagulation). All outcome events are adjudicated by an independent clinical events committee blinded to treatment allocation.
Measured: Within 7 days following randomization
Secondary outcomes (8)
Net benefit at 7 days (hierarchical composite outcome)
Hierarchical composite outcome assessed using a win-ratio approach, including the following components in order of priority: death possibly or confirmed to be related to pulmonary embolism (including death of undetermined cause), hemodynamic failure, respiratory failure, cardiac rhythm disorders requiring urgent treatment, major bleeding (ISTH definition), recurrent venous thromboembolism (symptomatic pulmonary embolism or proximal deep vein thrombosis requiring treatment or modification of anticoagulation), non-major clinically relevant bleeding, unscheduled hospital presentations (all causes), and cumulative length of hospital stay.
Measured: Within 7 days following randomization
Global health quality-of-life (short term)
Change over time in health-related quality of life assessed using the EQ-5D-5L questionnaire.
Measured: Baseline (Day 0), Day 3, Day 7
Functional status (short term)
Change over time in patient-reported functional status assessed using the Post-VTE Functional Status (PVFS) scale.
Measured: Pre-pulmonary embolism status estimated at inclusion, Day 0, Day 3, and Day 7
Composite incidence of major adverse events
Composite of all cause-death, recurrent venous thromboembolism and major bleeding
Measured: Within 14 days, 30 days, and 90 days following randomization
Individual components of safety outcomes
Incidence of all cause-death, recurrent venous thromboembolism, major bleeding, non-major clinically relevant bleeding, pulmonary embolism -related mortality and fatal bleeding.
Measured: Within 14 days, 30 days, and 90 days following randomization
Health-related quality of life
Longitudinal assessment of EQ-5D-5L scores over 90 days
Measured: Baseline (Day 0), Days 3, 7, 14, 30, and 90
Functional status
Longitudinal assessment of the Post-VTE Functional Status (PVFS) over 90 days
Measured: Pre-pulmonary embolism status estimated at inclusion, Day 0 and Days 3, 7, 14, 30 and 90
Hospital resources utilization
Number of unscheduled hospital presentations and cumulative lenght of in-hospital stay
Measured: Within 14 days, 30 days, and 90 days following inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, international, randomized, open-label, parallel-group trial comparing two management strategies in patients with acute pulmonary embolism without clinical severity criteria but with either right ventricular dysfunction or elevated cardiac troponin levels. Eligible patients are randomized in a 1:1 ratio to either home treatment with early discharge or standard hospitalization. Randomization is stratified by country and by the type of cardiac abnormality (right ventricular dysfunction or elevated troponin). All patients receive anticoagulation therapy according to current guidelines and local practice. Clinical outcomes are assessed during a 90-day follow-up period, with blinded adjudication of all outcome events.
- Masking
- None (open label)
- Enrolment
- 568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre-Marie ROY, Professor, Principal investigator, University Hospital of Angers, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506291
- Sponsor's protocol ID
- 49RC24_0325
- Other IDs
- 2026-A00754-47
- Acronym
- HOME-PE2
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during the study and relevant to the analyses will be made available after completion of the study to qualified researchers upon reasonable request to the coordinating investigator, subject to approval by the steering committee and in accordance with applicable regulations.
Publications
Hendriks SV, Klok FA, den Exter PL, Eijsvogel M, Faber LM, Hofstee HMA, Iglesias Del Sol A, Kroft LJM, Mairuhu ATA, Huisman MV. Right Ventricle-to-Left Ventricle Diameter Ratio Measurement Seems to Have No Role in Low-Risk Patients with Pulmonary Embolism Treated at Home Triaged by Hestia Criteria. Am J Respir Crit Care Med. 2020 Jul 1;202(1):138-141. doi: 10.1164/rccm.202002-0267LE. No abstract available.
PubMed 32203673Sanchez O, Benhamou Y, Bertoletti L, Constant J, Couturaud F, Delluc A, Elias A, Fischer AM, Frappe P, Gendron N, Girard P, Godier A, Gut-Gobert C, Laporte S, Mahe I, Mauge L, Meneveau N, Meyer G, Mismetti P, Parent F, Pernod G, Quere I, Revel MP, Roy PM, Salaun PY, Smadja DM, Sevestre MA. [Recommendations of good practice for the management of thromboembolic venous disease in adults. Short version]. Rev Mal Respir. 2019 Feb;36(2):249-283. doi: 10.1016/j.rmr.2019.01.003. Epub 2019 Feb 22. No abstract available. French.
PubMed 30799126Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
PubMed 31504429Zondag W, Mos IC, Creemers-Schild D, Hoogerbrugge AD, Dekkers OM, Dolsma J, Eijsvogel M, Faber LM, Hofstee HM, Hovens MM, Jonkers GJ, van Kralingen KW, Kruip MJ, Vlasveld T, de Vreede MJ, Huisman MV; Hestia Study Investigators. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost. 2011 Aug;9(8):1500-7. doi: 10.1111/j.1538-7836.2011.04388.x.
PubMed 21645235Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.
PubMed 34363386
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOME-PE2 : Home Treatment Versus Hospitalization in Patients With Acute Pulmonary Embolism, no Clinical Severity Criteria, and Either Right Ventricular Dysfunction or Elevated Troponin: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07506291
- Acronym / sponsor ID
- HOME-PE2 / 49RC24_0325
- Conditions
- Acute Pulmonary Embolism
- Keywords
- pulmonary embolism, Outpatient treatment, Home treatment, Hospitalization, Hestia rule, Right ventricular dysfunction, Troponin, Risk stratification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 568 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study (HOME-PE2) is a multicenter, randomized controlled trial comparing home treatment versus hospitalization in patients with acute pulmonary embolism (PE) who have no clinical severity criteria according to the Hestia rule but present either right ventricular dysfunction or elevated cardiac troponin levels.
While outpatient management is considered safe for low-risk PE patients, the optimal management of patients without clinical severity but with signs of right ventricular strain or myocardial injury remains uncertain, and current guidelines are inconsistent. As a result, most of these patients are still hospitalized despite limited evidence supporting this approach.
The primary objective is to assess whether home treatment is non-inferior to hospitalization in terms of safety, defined by the 7-day rate of adverse events according to the EARTH consensus. Secondary objectives include evaluation of net clinical benefit, quality of life, functional status, and healthcare resource utilization, as well as exploration of sex-related differences and cost-effectiveness.
A total of 568 adult patients with confirmed PE will be randomized (1:1) to either home treatment with early discharge or standard hospitalization. Patients will be followed for 90 days.
Detailed description
PE is a common and potentially life-threatening condition with a wide spectrum of clinical severity. In recent years, outpatient management has been demonstrated to be safe and effective in selected low-risk patients, particularly those without hemodynamic instability or significant comorbidities. Risk stratification tools such as the Hestia rule are widely used to identify patients eligible for home treatment based on clinical criteria.
However, uncertainty remains regarding the optimal management of patients who, despite having no clinical severity criteria according to the Hestia rule, present signs of right ventricular dysfunction (RVD) on imaging or elevated cardiac troponin levels. These markers are associated with an increased risk of adverse outcomes in some populations and are used in certain guidelines to classify patients as intermediate risk, often leading to hospitalization. In contrast, other recommendations do not require systematic cardiac assessment in clinically stable patients and support outpatient care in the absence of clinical severity criteria. As a result, clinical practice remains heterogeneous, and hospitalization is still frequently preferred in this subgroup despite limited prospective evidence.
The HOME-PE2 study is designed to address this gap by comparing two commonly used management strategies-home treatment and hospitalization-in this specific population. The trial aims to determine whether outpatient management is non-inferior to hospitalization in terms of short-term safety, while also evaluating broader patient-centered and health system outcomes.
HOME-PE2 is an international, multicenter, open-label, randomized controlled trial with blinded adjudication of clinical outcomes. Eligible adult patients presenting to the emergency department with objectively confirmed acute PE will be assessed for clinical severity using the Hestia rule. Patients without clinical criteria requiring hospitalization but with either RVD on imaging or elevated cardiac troponin levels will be randomized in a 1:1 ratio to either home treatment or hospitalization. Randomization will be stratified by country and by the qualifying cardiac abnormality.
Patients allocated to the home treatment group will be discharged early after inclusion, according to predefined timelines consistent with outpatient management. Patients assigned to the hospitalization group will receive standard inpatient care according to local practice. In both groups, anticoagulant therapy will be initiated and managed according to current guidelines and local protocols.
The study incorporates pragmatic features, including the comparison of usual care management strategies and flexibility in anticoagulation treatment according to local practice, thereby enhancing the generalizability of the findings to real-world clinical settings.
All patients will receive structured follow-up over a 90-day period. Clinical follow-up will include scheduled assessments shortly after inclusion and at later time points, either through in-person visits aligned with routine care or via telephone contact. In addition, patient-reported outcomes will be collected longitudinally using validated instruments assessing health-related quality of life and functional status. Data on healthcare utilization, including hospital readmissions and length of stay, will also be collected.
An independent clinical events committee, blinded to treatment allocation, will adjudicate all suspected outcome events based on predefined criteria to ensure consistency and reliability of endpoint assessment.
Beyond safety, the study will evaluate the overall net clinical benefit of home treatment compared with hospitalization, integrating multiple clinically relevant outcomes in a hierarchical framework. It will also assess the impact of management strategy on patient-reported outcomes, including quality of life and functional recovery, as well as healthcare resource use.
In addition, exploratory analyses will examine the influence of sex and living conditions on outcomes, in order to better understand potential differences in the feasibility and impact of outpatient care. A health-economic evaluation will be conducted to compare cost-utility and to estimate the potential budget impact of implementing outpatient management strategies in this population.
By rigorously comparing home treatment and hospitalization in patients with acute PE without clinical severity but with cardiac involvement, the HOME-PE2 trial aims to generate high-quality evidence to inform clinical guidelines, improve patient-centered care, and optimize the use of healthcare resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, international, randomized, open-label, parallel-group trial comparing two management strategies in patients with acute pulmonary embolism without clinical severity criteria but with either right ventricular dysfunction or elevated cardiac troponin levels. Eligible patients are randomized in a 1:1 ratio to either home treatment with early discharge or standard hospitalization. Randomization is stratified by country and by the type of cardiac abnormality (right ventricular dysfunction or elevated troponin). All patients receive anticoagulation therapy according to current guidelines and local practice. Clinical outcomes are assessed during a 90-day follow-up period, with blinded adjudication of all outcome events.
| Arm | Type | Receives |
|---|---|---|
| Home treatment | Experimental | Other: Home treatmentPatients randomized to this arm are managed as outpatients and discharged early after inclusion, no later than 24 hours after inclusion and no later than 48 hours after presentation to the emergency department. Anticoagulation therapy is initiated prior to discharge and continued in accordance with current guidelines and local practice. Patients receive structured follow-up in accordance with current guidelines and are instructed to seek medical attention in case of clinical deterioration, suspected recurrence of venous thromboembolism, or bleeding. |
| Hospitalization | Active comparator | Other: HospitalizationPatients randomized to this arm are managed as inpatients and admitted to a hospital medical unit for the management of acute PE according to local organization. Anticoagulation therapy is initiated and managed in accordance with current guidelines and local practice. The duration of hospitalization and timing of discharge are left to the discretion of the treating physician. Patients receive structured follow-up in accordance with current guidelines and are instructed to seek medical attention in case of clinical deterioration, suspected recurrence of venous thromboembolism, or bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presentation to the Emergency Department or unscheduled consultation in one of the participating centers
- Symptomatic PE objectively confirmed according to the European Society of Cardiology criteria 4 (either by i) a high-probability ventilation/perfusion lung scan, ii) a new contrast filling defect on spiral computed tomography, or iii) a new documentation by ultrasonography of a proximal DVT, i.e., thrombus in the popliteal vein or above, along with clinical signs of PE. All radiological tests used to diagnose PE will be interpreted by on-site radiologists or angiologists)
- No clinical criteria mandating hospitalization according to the Hestia rule, i.e., negative Hestia rule
- Right ventricular dysfunction - defined as a right ventricular (RV) to left ventricular (LV) diameter ratio > 1.0 on echocardiography (apical four-chamber or subcostal four-chamber view) or on CTPA (transverse plane) OR High-sensibility cardiac troponin I or T concentration above the upper limit of local normal value
- Insurance cover according to local legislation
Key exclusion criteria (9 listed)
- Shock or hypotension (defined as systolic blood pressure <90 mmHg or a systolic pressure drop by ≥40 mmHg, for >15 minutes, if not caused by new-onset arrhythmia, hypovolemia, or sepsis)
- Combined right ventricular dysfunction (RV/LV > 1.0 on imaging) AND troponin concentration above the upper limit of local normal value
- Free floating thrombi in the right atrium or ventricle, if identified by routine echocardiography or CTPA
- Active cancer other than basal or squamous-cell skin cancer defined at least with one of the following: i) cancer diagnosed within the last 6 months, ii) current anti-cancer treatment or during the 6 months before enrollment, iii) locally advanced or metastatic cancer
- PE diagnosis established since more than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home treatmentOutpatient management strategy for acute pulmonary embolism, including early discharge after diagnosis and initiation of anticoagulation therapy, with follow-up according to current guidelines and local practice. | Other | Home treatment |
| HospitalizationInpatient management strategy for acute pulmonary embolism, including hospital admission and standard care with anticoagulation therapy according to current guidelines and local practice. | Other | Hospitalization |
Primary outcome
7-day composite incidence of adverse events (EARTH criteria)
Time frame: Within 7 days following randomization
Composite outcome defined according to the EARTH consensus, including the occurrence of any of the following events within 7 days after randomization: death possibly or confirmed to be related to pulmonary embolism (including death of undetermined cause), hemodynamic failure, respiratory failure, cardiac rhythm disorders requiring urgent treatment, major bleeding (according to ISTH definition), or recurrent venous thromboembolism (symptomatic pulmonary embolism or proximal deep vein thrombosis requiring treatment or modification of anticoagulation). All outcome events are adjudicated by an independent clinical events committee blinded to treatment allocation.
8 secondary outcomes
Net benefit at 7 days (hierarchical composite outcome)
Time frame: Within 7 days following randomization
Global health quality-of-life (short term)
Time frame: Baseline (Day 0), Day 3, Day 7
Functional status (short term)
Time frame: Pre-pulmonary embolism status estimated at inclusion, Day 0, Day 3, and Day 7
Composite incidence of major adverse events
Time frame: Within 14 days, 30 days, and 90 days following randomization
Individual components of safety outcomes
Time frame: Within 14 days, 30 days, and 90 days following randomization
Health-related quality of life
Time frame: Baseline (Day 0), Days 3, 7, 14, 30, and 90
Functional status
Time frame: Pre-pulmonary embolism status estimated at inclusion, Day 0 and Days 3, 7, 14, 30 and 90
Hospital resources utilization
Time frame: Within 14 days, 30 days, and 90 days following inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 32203673Hendriks SV, Klok FA, den Exter PL, Eijsvogel M, Faber LM, Hofstee HMA, Iglesias Del Sol A, Kroft LJM, Mairuhu ATA, Huisman MV. Right Ventricle-to-Left Ventricle Diameter Ratio Measurement Seems to Have No Role in Low-Risk Patients with Pulmonary Embolism Treated at Home Triaged by Hestia Criteria. Am J Respir Crit Care Med. 2020 Jul 1;202(1):138-141. doi: 10.1164/rccm.202002-0267LE. No abstract available.
- Background: PubMed 30799126Sanchez O, Benhamou Y, Bertoletti L, Constant J, Couturaud F, Delluc A, Elias A, Fischer AM, Frappe P, Gendron N, Girard P, Godier A, Gut-Gobert C, Laporte S, Mahe I, Mauge L, Meneveau N, Meyer G, Mismetti P, Parent F, Pernod G, Quere I, Revel MP, Roy PM, Salaun PY, Smadja DM, Sevestre MA. [Recommendations of good practice for the management of thromboembolic venous disease in adults. Short version]. Rev Mal Respir. 2019 Feb;36(2):249-283. doi: 10.1016/j.rmr.2019.01.003. Epub 2019 Feb 22. No abstract available. French.
- Background: PubMed 31504429Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Background: PubMed 21645235Zondag W, Mos IC, Creemers-Schild D, Hoogerbrugge AD, Dekkers OM, Dolsma J, Eijsvogel M, Faber LM, Hofstee HM, Hovens MM, Jonkers GJ, van Kralingen KW, Kruip MJ, Vlasveld T, de Vreede MJ, Huisman MV; Hestia Study Investigators. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost. 2011 Aug;9(8):1500-7. doi: 10.1111/j.1538-7836.2011.04388.x.
- Background: PubMed 34363386Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during the study and relevant to the analyses will be made available after completion of the study to qualified researchers upon reasonable request to the coordinating investigator, subject to approval by the steering committee and in accordance with applicable regulations.
Related trials for Acute Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Not yet recruitingPhase 3
Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
Pulmonary Embolism
Not yet recruiting
Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Acute Pulmonary Embolism
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre-Marie ROY, Professor principal investigator
University Hospital of Angers, France
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home treatment and Hospitalization in people with Acute Pulmonary Embolism, run by University Hospital, Angers at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Marie ROY, Professor (+ 33 (0)2 41 35 37 18, PMRoy@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day composite incidence of adverse events (EARTH criteria) (time frame: Within 7 days following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07506291, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.