Acute Heart Failure (AHF)PEHFNCT07499661
Pulmonary Embolism in Patients With Acute Heart Failure (PEHF Study)
A study testing Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithm in people with Acute Heart Failure (AHF) and Pulmonary Embolism (Diagnosis), run by University Hospital, Angers at 10 sites in France.
Trial summary
This study focuses on two serious and common medical conditions: heart failure and pulmonary embolism (a blood clot in the lungs). Heart failure happens when the heart cannot pump blood effectively, and it is one of the main reasons older adults are admitted to the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Pulmonary Embolism (Diagnosis), Venous Thromboembolism
- What is being tested?
- Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 10 sitesFrance
- Study dates
- 15 Jul 2026to Oct 2028
- 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
- Adult patient (≥18 years)
- Admission to the emergency department or cardiology unit of a participating center
- Recent onset or worsening dyspnea and/or orthopnea
- Diagnosis of acute heart failure defined by recent dyspnea associated with at least one of the following:
- Bilateral pulmonary crackles on auscultation and/or peripheral edema
- Signs of pulmonary congestion on chest X-ray or lung/cardiac ultrasound
Show all 10Show fewer
- Elevated natriuretic peptide levels (BNP or NT-proBNP)
- Documented history of heart failure (known chronic heart failure or prior hospitalization for acute heart failure)
- Patient affiliated with or beneficiary of a social security system
- Patient able and willing to provide free, informed, and written consent
Who cannot join
- Shock state suggesting cardiogenic shock and/or severe pulmonary embolism
- Severe respiratory distress at inclusion preventing appropriate positioning or performance of imaging examinations
- Evidence of acute coronary syndrome on electrocardiogram at admission
- Severe renal impairment (creatinine clearance <30 mL/min)
- Known hypersensitivity or allergy to iodinated contrast agents
- Ongoing therapeutic anticoagulation for more than 48 hours prior to admission
Show all 11Show fewer
- Hospitalization for more than 48 hours prior to inclusion
- Inability to ensure 90-day follow-up (e.g., end-of-life situation, no fixed address, patient not reachable)
- Inadequate understanding of the French language preventing proper study information and consent
- Pregnant, breastfeeding, or postpartum women
- Individuals under legal protection or other vulnerable populations, including minors and protected adults, in accordance with applicable public health regulations (Articles L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
Agen Hospital, Emergency department
Agen, 47923
Maë Adrian, Doctor, +33 (0)5.53.69.73.18, adrianm@ch-agen-nerac.fr
- Recruiting
Angers University Hospital, Emergency Department
Angers, 49000
Delphine Douillet, Professor, +33 (0)2.41.35.36.27, Delphine.Douillet@chu-angers.fr
- Not yet recruiting
Brest University Hospital (site Cavale Blanche), Cardiology Department
Brest, 29200
Romain Didier, Professor, +33 (0)2.98.34.73.92, romain.didier@chu-brest.fr
- Not yet recruiting
Tours University Hospital (site Trousseau), Adult Emergency Department
Chambray-lès-Tours, 37170
Thomas Moumneh, Doctor, +33 (0)2.47.47.47.47, t.moumneh@chu-tours.fr
- Not yet recruiting
Cholet Hospital, Emergency Department
Cholet, 49300
Violette Boiveau, Doctor, +33 (0)2.41.49.69.85, violette.boiveau@ch-cholet.fr
- Not yet recruiting
Clermont-Ferrand University Hospital, Emergency Department
Clermont-Ferrand, 63000
Romain Durif, Doctor, +33 (0)4.73.75.19.99, rdurif@chu-clermontferrand.fr
- Not yet recruiting
Grenoble Alpes University Hospital, Adult Emergency Department
La Tronche, 38700
Damien Viglino, Professor, +33 (0)4.76.76.67.84, dviglino@chu-grenoble.fr
- Not yet recruiting
Lyon University Hospital (site Edouard Herriot), Emergency Department
Lyon, 69003
Youri Yordanov, Professor, +33 (0)4.72.11.22.93, youri.yordanov@chu-lyon.fr
- Not yet recruiting
Poitiers University Hospital, Emergency Department
Poitiers, 86000
Nicolas Marjanovic, Doctor, +33 (0)5.49.44.44.44, nicolas.marjanovic@chu-poitiers.fr
- Not yet recruiting
Toulouse University Hospital, Emergency Department
Toulouse, 31000
Frederic Balen, Doctor, +33 (0)561772579, balen.f@chu-toulouse.fr
About this study
Official title: Pulmonary Embolism in Patients With Acute Heart Failure: A Pragmatic Cluster-Randomized Trial (PEHF Study)
This study focuses on two serious and common medical conditions: heart failure and pulmonary embolism (a blood clot in the lungs). Heart failure happens when the heart cannot pump blood effectively, and it is one of the main reasons older adults are admitted to the hospital. Pulmonary embolism can be life-threatening and may worsen heart failure or even trigger it.
Doctors believe that pulmonary embolism may often go undetected in patients who come to the hospital with symptoms of acute heart failure, such as sudden shortness of breath. This is because both conditions can cause similar symptoms, making it difficult to tell them apart. As a result, doctors may sometimes assume the symptoms are only due to heart failure and not investigate further for a possible blood clot.
Read more
However, missing a pulmonary embolism can have serious consequences. Studies suggest that some patients with heart failure who die may actually have had an undiagnosed pulmonary embolism. Current medical guidelines recommend checking for pulmonary embolism when the cause of breathing problems is unclear, but in real-life practice, this is not always done.
The goal of this study is to find out whether pulmonary embolism is underdiagnosed in patients with suspected acute heart failure and whether systematically testing for it could improve patient outcomes.
To do this, the study will compare two approaches in several hospitals. In half of the hospitals, doctors will follow their usual practice and decide case by case whether to test for pulmonary embolism. In the other half, doctors will systematically test all eligible patients for pulmonary embolism using recommended diagnostic methods.
Adult patients admitted with recent or worsening breathing difficulties and signs of acute heart failure may be included in the study, provided they give their consent. Researchers will collect information about their symptoms, tests, diagnosis, and treatments.
Patients will be monitored during their hospital stay and for three months afterward. The study will track important outcomes such as survival, new blood clots, bleeding events, repeated hospital visits for breathing problems, and overall time spent in the hospital.
The researchers expect to include about 740 patients in total. They estimate that pulmonary embolism may be found in about 1% of patients with usual care, but up to 5% when doctors systematically look for it.
This study aims to better understand how often pulmonary embolism occurs in patients with acute heart failure and whether more systematic testing could lead to earlier diagnosis and better care. The results could help improve medical practice and reduce complications or deaths related to missed diagnoses.
- Being tested
- Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithm
- Keywords
- Cluster-randomized trial
- Medical subject headings
- Pulmonary Embolism, Disease, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithmDiagnostic test
In intervention centers, physicians will systematically screen all patients for pulmonary embolism (PE) using guideline-recommended algorithms. The revised Geneva score will be assessed for each patient. If clinical probability is low or moderate (≤10), highly sensitive D-dimer testing will be performed. PE will be excluded if D-dimer levels are below 500 µg/L (under 50 years) or below the age-adjusted threshold (age × 10 µg/L for patients ≥50 years).
For patients with elevated D-dimers or high clinical probability, a 4-point compression venous ultrasound will be performed. If positive, PE will be confirmed. If negative or inconclusive, CT pulmonary angiography will be conducted. All diagnostic procedures must be completed within 48 hours of admission.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Not described Receives: Diagnostic Test: Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithm |
| Observational arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pulmonary embolism
Rate of pulmonary embolism (PE) diagnosed within 48 hours after hospital admission. PE must be objectively confirmed and the diagnosis validated by an independent adjudication committee blinded to study group allocation.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Delphine Douillet, Professor, Principal investigator, University Hospital of Angers, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499661
- Sponsor's protocol ID
- 49RC25_0434
- Other IDs
- 2025-A02492-47
- Acronym
- PEHF
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism in Patients With Acute Heart Failure: A Pragmatic Cluster-Randomized Trial (PEHF Study)
- ClinicalTrials.gov ID
- NCT07499661
- Acronym / sponsor ID
- PEHF / 49RC25_0434
- Keywords
- Cluster-randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 30 Mar 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 focuses on two serious and common medical conditions: heart failure and pulmonary embolism (a blood clot in the lungs). Heart failure happens when the heart cannot pump blood effectively, and it is one of the main reasons older adults are admitted to the hospital. Pulmonary embolism can be life-threatening and may worsen heart failure or even trigger it.
Doctors believe that pulmonary embolism may often go undetected in patients who come to the hospital with symptoms of acute heart failure, such as sudden shortness of breath. This is because both conditions can cause similar symptoms, making it difficult to tell them apart. As a result, doctors may sometimes assume the symptoms are only due to heart failure and not investigate further for a possible blood clot.
However, missing a pulmonary embolism can have serious consequences. Studies suggest that some patients with heart failure who die may actually have had an undiagnosed pulmonary embolism. Current medical guidelines recommend checking for pulmonary embolism when the cause of breathing problems is unclear, but in real-life practice, this is not always done.
The goal of this study is to find out whether pulmonary embolism is underdiagnosed in patients with suspected acute heart failure and whether systematically testing for it could improve patient outcomes.
To do this, the study will compare two approaches in several hospitals. In half of the hospitals, doctors will follow their usual practice and decide case by case whether to test for pulmonary embolism. In the other half, doctors will systematically test all eligible patients for pulmonary embolism using recommended diagnostic methods.
Adult patients admitted with recent or worsening breathing difficulties and signs of acute heart failure may be included in the study, provided they give their consent. Researchers will collect information about their symptoms, tests, diagnosis, and treatments.
Patients will be monitored during their hospital stay and for three months afterward. The study will track important outcomes such as survival, new blood clots, bleeding events, repeated hospital visits for breathing problems, and overall time spent in the hospital.
The researchers expect to include about 740 patients in total. They estimate that pulmonary embolism may be found in about 1% of patients with usual care, but up to 5% when doctors systematically look for it.
This study aims to better understand how often pulmonary embolism occurs in patients with acute heart failure and whether more systematic testing could lead to earlier diagnosis and better care. The results could help improve medical practice and reduce complications or deaths related to missed diagnoses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Diagnostic Test: Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithm |
| Observational arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patient (≥18 years)
- Admission to the emergency department or cardiology unit of a participating center
- Recent onset or worsening dyspnea and/or orthopnea
- Diagnosis of acute heart failure defined by recent dyspnea associated with at least one of the following:
- Patient affiliated with or beneficiary of a social security system
Key exclusion criteria (11 listed)
- Shock state suggesting cardiogenic shock and/or severe pulmonary embolism
- Severe respiratory distress at inclusion preventing appropriate positioning or performance of imaging examinations
- Evidence of acute coronary syndrome on electrocardiogram at admission
- Severe renal impairment (creatinine clearance <30 mL/min)
- Known hypersensitivity or allergy to iodinated contrast agents
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 |
|---|---|---|
| Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithmIn intervention centers, physicians will systematically screen all patients for pulmonary embolism (PE) using guideline-recommended algorithms. The revised Geneva score will be assessed for each patient. If clinical probability is low or moderate (≤10), highly sensitive D-dimer testing will be performed. PE will be excluded if D-dimer levels are below 500 µg/L (under 50 years) or below the age-adjusted threshold (age × 10 µg/L for patients ≥50 years). For patients with elevated D-dimers or high clinical probability, a 4-point compression venous ultrasound will be performed. If positive, PE will be confirmed. If negative or inconclusive, CT pulmonary angiography will be conducted. All diagnostic procedures must be completed within 48 hours of admission. | Diagnostic test | Interventional arm |
Primary outcome
Rate of pulmonary embolism
Time frame: 48 hours
Rate of pulmonary embolism (PE) diagnosed within 48 hours after hospital admission. PE must be objectively confirmed and the diagnosis validated by an independent adjudication committee blinded to study group allocation.
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 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Heart Failure (AHF)
RecruitingObservational study
Comprehensive Clinical Prediction Rule for Acute Heart Failure
Acute Heart Failure (AHF)
Not yet recruiting
Ketone Ester for Treatment Of Acute Heart Failure
Acute Heart Failure
Not yet recruiting
Routine Magnesium Testing and Supplementation in Acute Heart Failure (MAG-HF)
Acute Heart Failure (AHF)
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
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.
Delphine Douillet, Professor principal investigator
University Hospital of Angers, France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithm in people with Acute Heart Failure (AHF) and Pulmonary Embolism (Diagnosis), run by University Hospital, Angers at 10 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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Delphine Douillet, Professor (+33 (0)2 41 35 36 27, Delphine.Douillet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pulmonary embolism (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.