The Heart Health After Cardiac Treatment Study

NCT07158515 | Recruiting

• 1 other identifier: 23-40216
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine whether participation in a tailored cardiac rehabilitation program delivered in a safety net setting, compared to usual care referral to an outside cardiac rehabilitation program, results in greater participation in cardiac rehabilitation.

Conditions

Cardiac Rehabilitation

Keywords

comparative effectiveness; safety net

Outcome Measures

Primary Outcomes (1)

• Participation in at least 1 session of cardiac rehabilitation

  In each arm, the proportion of participants who attended at least 1 cardiac rehabilitation session will be calculated.

  12 months

Secondary Outcomes (5)

• Completion of cardiac rehabilitation

  12 months

• Change in six-minute walk distance

  12 months

• Change in six-minute walk distance

  3 months

• Change in quality of life

  12 months

• Change in quality of life

  3 months

Study Arms (2)

Tailored cardiac rehabilitation in a safety net setting

EXPERIMENTAL

A 12-week program of exercise training and health behavior counseling consisting of every other week group sessions (exercise and health behavior education) and every other week individual counseling sessions that address the cardiac rehabilitation core components.

Behavioral: Tailored cardiac rehabilitation

Referral to an outside cardiac rehabilitation program

ACTIVE COMPARATOR

Referral to a cardiac rehabilitation program outside of the safety net hospital setting.

Behavioral: Referral to an external cardiac rehabilitation program

Interventions

Tailored cardiac rehabilitation BEHAVIORAL

The program will address the core components of CR.21 Each of the program components will have an individualized assessment with plan and goals set at the program intake visit. The 12-week program will alternate between group and individual sessions each week. Individualized plans will be reviewed every two weeks at the participant individual sessions. Group sessions will address physical activity, nutrition, and other program topics. Duration of the program was chosen to resemble a typical 12-week cardiac rehabilitation intervention. However, the program will have a greater emphasis on cultural tailoring, language concordance, lowering burden of real-time in-person attendance, motivational coaching, and addressing psychosocial needs.

Tailored cardiac rehabilitation in a safety net setting

Referral to an external cardiac rehabilitation program BEHAVIORAL

Participants will be referred to an external cardiac rehabilitation program outside of the safety net setting. This is the current standard of care.

Referral to an outside cardiac rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Referred for cardiac rehabilitation for a covered indication:
• Acute myocardial infarction
• Percutaneous coronary intervention
• Coronary artery bypass surgery
• Heart valve repair or replacement
• Heart transplant
• Chronic stable angina
• Chronic systolic heart failure (EF \<=35%)
• Able to communicate in English, Spanish, or Cantonese
• Able to consent for self

You may not qualify if:

• Currently enrolled in hospice.
• Provider says patient may not be approached for participation in this study.

Sponsors & Collaborators

• University of California, San Francisco: lead
• This work was made possible by residual class settlement funds in the matter of April Krueger v. Wyeth, Inc., Case No. 03-cv-2496 (US District Court, SD of CA): collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Study Officials

• Alexis Beatty, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisa Boyd, MPH

CONTACT

415-514-7905; heartact@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: November 28, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

US (1)