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

Not Applicable

Recruiting

• Conditions: Acute Pulmonary Embolism

• Registration Number: NCT06784492
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-02-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2027-10-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change in cardiac effort	Baseline and 3 months	Change in cardiac effort is measured as the number of heart beats used during the 6-minute walk test.

Secondary Outcome Measures

Name	Time	Method
Mean number of health care visits (Health Care Utilization)	3 months	Subject medical records will be reviewed to determine the number of utilizations.
Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score	baseline and 3 months	The pulmonary embolism quality of life questionnaire ranges from 1 to 27, with higher scores indicating worse outcomes.
Mean change in 6 minute walk distance	baseline and 3 months
Mean change in activity as measured by Actigraph	baseline and 3 months	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.
mean change in diagnoses	baseline and month 3	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States