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Active, Not Recruiting

NCT Number: NCT07158515

The Heart Health After Cardiac Treatment Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Participation in at least 1 session of cardiac rehabilitation

    Time frame: 12 months

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

Secondary outcomes

  1. Completion of cardiac rehabilitation

    Time frame: 12 months

    In each arm, the proportion of participants who attend at least 2/3 of expected sessions of cardiac rehabilitation (24 sessions in the active comparator arm and 8 sessions in the experimental arm) will be calculated.

  2. Change in six-minute walk distance

    Time frame: 12 months

    Change in distance walked in 6 minutes, following a standard protocol, from baseline to 12 months.

  3. Change in six-minute walk distance

    Time frame: 3 months

    Change in distance walked in 6 minutes, following a standard protocol, from baseline to 3 months.

  4. Change in quality of life

    Time frame: 12 months

    Change in PROMIS Global Health physical and mental subscores between baseline and 12 months. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical and mental health subscales each consist of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health.

  5. Change in quality of life

    Time frame: 3 months

    Change in PROMIS Global Health physical and mental subscores between baseline and 3 months. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical and mental health subscales each consist of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • 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)

Registry information

Acronym: HEART-ACT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Jul 6, 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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