Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism (ERASE-PE)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pulmonary Embolism
• Intervention / Treatment: Behavioral: Healthy Living Intervention-1; Behavioral: Healthy Living Intervention-2

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel J Lachant, DO; Phone Number: 5852769357; Email: daniel_lachant@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Recruiting
      • University of Rochester Medical Center
      • Principal Investigator: Daniel Lachant, DO
      • Contact: Daniel Lachant, DO; Phone Number: 585 486 0147; Email: Daniel_Lachant@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Living Intervention-1; Participants who receive daily messages about a healthy intervention.	Behavioral: Healthy Living Intervention-1; Participants will receive a text or email each day with instructions about a healthy intervention.
Active Comparator: Healthy Living Intervention-2; Participants who receive daily messages about a different healthy intervention.	Behavioral: Healthy Living Intervention-2; Participants will receive a text or email each day with instructions about a healthy intervention.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of health care visits (Health Care Utilization)	Subject medical records will be reviewed to determine the number of utilizations.	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.	baseline and 3 months
Mean change in 6 minute walk distance		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.	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.	baseline and month 3

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: actigraphy; Six minute walk; Recovery acute pulmonary embolism; Cardiac Effort
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pulmonary Embolism; Embolism
• Other Study ID Numbers: STUDY00009895; 1K23HL171867 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No