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NCT Number: NCT06784492

Incorporating Healthy Living Strategies to Aid in 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.

Recruiting

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Key information

Conditions

Acute Pulmonary Embolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location status: Recruiting

Location contact

Daniel Lachant, DO

CONTACT

[email protected]

585 486 0147

Daniel Lachant, DO

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Healthy Living Intervention-1

Behavioral

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

Healthy Living Intervention-2

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean number of health care visits (Health Care Utilization)

    Time frame: 3 months

    Subject medical records will be reviewed to determine the number of utilizations.

  2. Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score

    Time frame: baseline and 3 months

    The pulmonary embolism quality of life questionnaire ranges from 1 to 27, with higher scores indicating worse outcomes.

  3. Mean change in 6 minute walk distance

    Time frame: baseline and 3 months

  4. Mean change in activity as measured by Actigraph

    Time frame: 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.

  5. mean change in diagnoses

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel J Lachant, DO

CONTACT

[email protected]

5852769357

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Recovery After Acute Pulmonary Embolism

Acronym: ERASE-PE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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