Acute Pulmonary EmbolismERASE-PENCT06784492
Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism
A study testing Healthy Living Intervention-1 and Healthy Living Intervention-2 in people with Acute Pulmonary Embolism, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. 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?
- Healthy Living Intervention-1 and Healthy Living Intervention-2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to 1 Dec 2027
- 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
- English speaking (>18 years old). Daily messages will be sent in English.
- Acute PE with at least one of the following:
- any right ventricular enlargement or dysfunction on echocardiogram;
- CT Angiogram reporting any right ventricular enlargement; or
- elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
- Rate controlled atrial arrythmias (resting heart rate <110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
- Subjects do need to take prescribed anticoagulation.
Who cannot join
- Pregnancy.
- Cardiac Effort >3.5 beats/m during 6MWT.
- Resting tachycardia >110 beats/m at hospital discharge.
- Chronic Thromboembolic Pulmonary Hypertension
- Systolic blood pressure >180 mmHg at hospital discharge.
- Inability to walk.
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- Estimated prognosis <12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
- Advanced neurologic disease and would not be able to comply with the messages.
- Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14620
Daniel Lachant, DO, 585 486 0147, Daniel_Lachant@urmc.rochester.edu
Daniel Lachant, DO
About this study
Official title: Recovery After Acute Pulmonary Embolism
The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- Healthy Living Intervention-1, Healthy Living Intervention-2
- Keywords
- Recovery acute pulmonary embolism, Six minute walk, Cardiac Effort, actigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Living Intervention-1Behavioural
Participants will receive a text or email each day with instructions about a healthy intervention.
Healthy Living Intervention-2Behavioural
Participants will receive a text or email each day with instructions about a healthy intervention.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Living Intervention-1 | Experimental | Participants who receive daily messages about a healthy intervention. Receives: Behavioral: Healthy Living Intervention-1 |
| Healthy Living Intervention-2 | Active comparator | Participants who receive daily messages about a different healthy intervention. Receives: Behavioral: Healthy Living Intervention-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in cardiac effort
Change in cardiac effort is measured as the number of heart beats used during the 6-minute walk test.
Measured: Baseline and 3 months
Secondary outcomes (5)
Mean number of health care visits (Health Care Utilization)
Subject medical records will be reviewed to determine the number of utilizations.
Measured: 3 months
Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score
The pulmonary embolism quality of life questionnaire ranges from 1 to 27, with higher scores indicating worse outcomes.
Measured: baseline and 3 months
Mean change in 6 minute walk distance
Measured: baseline and 3 months
Mean change in activity as measured by Actigraph
The Actigraph triaxial accelerometer will be used to monitor the amount of activity taken at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the amount of activity.
Measured: baseline and 3 months
mean change in diagnoses
Investifators will sum up the number of post-PE syndrome and CTEPH diagnoses and report the mean change in the sum between baseline and month 3.
Measured: baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start27 Feb 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Daniel Lachant, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784492
- Sponsor's protocol ID
- STUDY00009895
- Other IDs
- 1K23HL171867
- Acronym
- ERASE-PE
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06784492
- Acronym / sponsor ID
- ERASE-PE / STUDY00009895
- Conditions
- Acute Pulmonary Embolism
- Keywords
- Recovery acute pulmonary embolism, Six minute walk, Cardiac Effort, actigraphy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Jan 2025 (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.
The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Living Intervention-1 | Experimental | Behavioral: Healthy Living Intervention-1Participants who receive daily messages about a healthy intervention. |
| Healthy Living Intervention-2 | Active comparator | Behavioral: Healthy Living Intervention-2Participants who receive daily messages about a different healthy intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking (>18 years old). Daily messages will be sent in English.
- Acute PE with at least one of the following:
- Rate controlled atrial arrythmias (resting heart rate <110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
- Subjects do need to take prescribed anticoagulation.
Key exclusion criteria (9 listed)
- Pregnancy.
- Cardiac Effort >3.5 beats/m during 6MWT.
- Resting tachycardia >110 beats/m at hospital discharge.
- Chronic Thromboembolic Pulmonary Hypertension
- Systolic blood pressure >180 mmHg at hospital discharge.
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 |
|---|---|---|
| Healthy Living Intervention-1Participants will receive a text or email each day with instructions about a healthy intervention. | Behavioural | Healthy Living Intervention-1 |
| Healthy Living Intervention-2Participants will receive a text or email each day with instructions about a healthy intervention. | Behavioural | Healthy Living Intervention-2 |
Primary outcome
Mean change in cardiac effort
Time frame: Baseline and 3 months
Change in cardiac effort is measured as the number of heart beats used during the 6-minute walk test.
5 secondary outcomes
Mean number of health care visits (Health Care Utilization)
Time frame: 3 months
Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score
Time frame: baseline and 3 months
Mean change in 6 minute walk distance
Time frame: baseline and 3 months
Mean change in activity as measured by Actigraph
Time frame: baseline and 3 months
mean change in diagnoses
Time frame: baseline and month 3
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 8 Apr 2026.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Living Intervention-1 and Healthy Living Intervention-2 in people with Acute Pulmonary Embolism, run by University of Rochester at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 8 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 1 site in United States. 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 Daniel J Lachant, DO (5852769357, daniel_lachant@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in cardiac effort (time frame: Baseline and 3 months). 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 8 Apr 2026.