Recruiting

Healthy Living Strategies

Sponsor:

University of Rochester

Code:

NCT06784492

Conditions

Acute Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Healthy Living Intervention-1

Healthy Living Intervention-2

Study Details

Brief 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. 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

Study ID

NCT06784492

Start date

Feb 27, 2025

Status verified date

Apr, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. English speaking (>18 years old). Daily messages will be sent in English.
2. Acute PE with at least one of the following:

1. any right ventricular enlargement or dysfunction on echocardiogram;
2. CT Angiogram reporting any right ventricular enlargement; or
3. elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
3. 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.
4. Subjects do need to take prescribed anticoagulation.

Exclusion Criteria:

1. Pregnancy.
2. Cardiac Effort >3.5 beats/m during 6MWT.
3. Resting tachycardia >110 beats/m at hospital discharge.
4. Chronic Thromboembolic Pulmonary Hypertension
5. Systolic blood pressure >180 mmHg at hospital discharge.
6. Inability to walk.
7. Estimated prognosis <12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
8. Advanced neurologic disease and would not be able to comply with the messages.
9. Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Healthy Living Intervention-1

Participants who receive daily messages about a healthy intervention.

active comparator: Healthy Living Intervention-2

Participants who receive daily messages about a different healthy intervention.

Interventions

Healthy Living Intervention-1

Participants will receive a text or email each day with instructions about a healthy intervention.

Healthy Living Intervention-2

Participants will receive a text or email each day with instructions about a healthy intervention.

Primary outcome measure

  • Mean change in cardiac effort [ Time Frame: Baseline and 3 months ]

Central Contacts and Locations

Central contacts

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14620

Contacts

Principal Investigator:

Daniel Lachant, DO

More Information

Sponsor

University of Rochester

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Recovery acute pulmonary embolism
  • Six minute walk
  • Cardiac Effort
  • actigraphy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-04-08.