Cardiac RehabilitationHEART-ACTNCT07158515
The Heart Health After Cardiac Treatment Study
A study testing Tailored cardiac rehabilitation and Referral to an external cardiac rehabilitation program in people with Cardiac Rehabilitation, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Tailored cardiac rehabilitation and Referral to an external cardiac rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- Heart transplant
- Chronic stable angina
- Chronic systolic heart failure (EF <=35%)
- Able to communicate in English, Spanish, or Cantonese
- Able to consent for self
Who cannot join
- Currently enrolled in hospice.
- Provider says patient may not be approached for participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this 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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Tailored cardiac rehabilitation, Referral to an external cardiac rehabilitation program
- Keywords
- comparative effectiveness, safety net
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored cardiac rehabilitationBehavioural
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 programBehavioural
Participants will be referred to an external cardiac rehabilitation program outside of the safety net setting. This is the current standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Referral to an external cardiac rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Completion of cardiac rehabilitation
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.
Measured: 12 months
Change in six-minute walk distance
Change in distance walked in 6 minutes, following a standard protocol, from baseline to 12 months.
Measured: 12 months
Change in six-minute walk distance
Change in distance walked in 6 minutes, following a standard protocol, from baseline to 3 months.
Measured: 3 months
Change in quality of life
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.
Measured: 12 months
Change in quality of life
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start28 Nov 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or 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)
- Responsible party
- Principal investigator, Alexis Beatty, MD, University of California, San Francisco
- Investigators
- Alexis Beatty, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158515
- Sponsor's protocol ID
- 23-40216
- Acronym
- HEART-ACT
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the conclusion of the study, we will follow local procedures and laws regarding the sharing of individual participant data. Any data that are shared will be de-identified prior to sharing.