Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism

NCT ID: NCT06784492

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Healthy Living Intervention-1

Participants who receive daily messages about a healthy intervention.

Group Type EXPERIMENTAL

Healthy Living Intervention-1

Intervention Type BEHAVIORAL

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

Healthy Living Intervention-2

Participants who receive daily messages about a different healthy intervention.

Group Type ACTIVE_COMPARATOR

Healthy Living Intervention-2

Intervention Type BEHAVIORAL

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

Interventions

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Healthy Living Intervention-1

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

Intervention Type BEHAVIORAL

Healthy Living Intervention-2

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Daniel Lachant

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel J Lachant, DO

Role: CONTACT

5852769357

Facility Contacts

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Daniel Lachant, DO

Role: primary

585 486 0147

Other Identifiers

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1K23HL171867

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009895

Identifier Type: -

Identifier Source: org_study_id

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