Cardiac RehabilitationACT-HFNCT07858318
Accelerated (Intensive) Cardiac Training for Heart Failure Patients
A study testing Early Referral in people with Cardiac Rehabilitation and Heart Failure, run by Washington University School of Medicine.
Trial summary
The purpose of this study is to see if patients undergoing accelerated Intensive Cardiac Rehabilitation (ICR) (2 weeks after discharge) will improve exercise performance as well as on measures of quality of life after a cardiac hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Heart Failure
- What is being tested?
- Early Referral
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years of age at the time of consent
- Diagnosis of HFrEF
- EF <35% within 3 months of hospital discharge
- Current hospitalization for a cardiac event (an approved cardiac diagnosis, such as chronic angina, recent MI (heart attack), cardiac surgery, or recent percutaneous coronary intervention (PCI) e.g., stent placement)
- Agreeable to complete 24 days of ICR and study requirements
- Ability and willingness to sign the ICF
- Referred to intensive cardiac rehabilitation at Washington University Heart Care Institute (HCI) at Barnes-Jewish West County Hospital (BJWCH).
Who cannot join
- Diagnosis of dementia
- Significant orthopedic limitations (e.g., double amputee) (walking with a walker is acceptable)
- Discharge to rehab facility or nursing home
- Pregnant women
- Currently enrolled in Hospice, not expected to live for 12 months
- Undergoing treatment for any type of cancer other than skin cancer
- History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to participants or interfere with study procedures, evaluation, or completion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Accelerated (Intensive) Cardiac Training for Heart Failure Patients (ACT-HF)
The purpose of this study is to see if patients undergoing accelerated Intensive Cardiac Rehabilitation (ICR) (2 weeks after discharge) will improve exercise performance as well as on measures of quality of life after a cardiac hospitalization.
Read the detailed description
The goal of this study is to evaluate the safety and effectiveness of initiating ICR (Intensive Cardiac Rehabilitation) at 2 weeks versus 6 weeks following hospital discharge in patients with HFrEF (Heart Failure with reduced Ejection Fraction). This is a randomized, controlled trial with two parallel groups. The Early Intervention Group with ICR initiated 2 weeks ±2 weeks following hospital discharge and the Usual Care Group with ICR initiated 6 weeks ±2 weeks after hospital discharge. Potential participants will be identified at Missouri Baptist Medical Center and referred for ICR at the HCI (Heart Care Institute) at Barnes Jewish West County Hospital (BJWCH). This study is being funded by the Missouri Baptist Healthcare Foundation.
To be evaluable, participants must complete a minimum of 24 ICR days, scheduled up to three days per week, with the option of completing a maximum of 36 ICR days over a period of up to 12-to-15-weeks post hospital discharge. The study team will analyze the ICR data from the start of ICR through 24 days of ICR. Data after 24 days will only include information on whether a participant continues to complete the maximum 36 days of ICR. During the trial, participants will complete performance tests and PRO (Participant Reported Outcome) surveys and questionnaires. Performance tests include a 6MWT (six minute walk test), a SPPB test (Short Performance Battery Test), and a handgrip test and will be completed at baseline, and the start of ICR and at the end of the completion of the 24th day of ICR.
PROs include a Cardiac Self-Efficacy Questionnaire (survey), Dartmouth COOP General Health Questionnaire (survey), PHQ-9 (survey), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Beck Depression Score (BDS), Rate Your Plate (RYP) and Duke Activity Status Index (DASI). PROs will be completed during baseline, start of ICR, and at the end of the 24th day of ICR.
The Early Intervention Group will repeat performance assessments and PROs 6-weeks (approximately 4-weeks post ICR start-up) following hospital discharge.
- Conditions
- Cardiac Rehabilitation, Heart Failure
- Being tested
- Early Referral, Standard Of Care (SOC) + Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early ReferralOther
Patients will be early referred (2 wks vs 6wks) to cardiac rehabilitation to see if there are benefits to early referral.
Standard Of Care (SOC) + PlaceboOther
Normal Standard of care 6 week referral time.
| Study group | Role | What they receive |
|---|---|---|
| 2 weeks post discharge group | Active comparator | Participants will be randomized into a 2 week post discharge group that will start cardiac rehabilitation 2 weeks after discharge compared to normal SOC at 6 weeks post discharge. Receives: Other: Early Referral |
| 6 weeks post discharge group (SOC) | Placebo comparator | Participants will be randomized into the SOC 6 week post discharge group. Receives: Other: Standard Of Care (SOC) + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Accelerated ICR 2 weeks and 6 weeks post-hospital discharge
To evaluate safety/tolerability of accelerated ICR beginning 2 weeks post-hospital discharge compared to usual standard care ICR beginning 6 weeks post-hospital discharge in patients with HFrEF. Safety will be determined by incidence of adverse events from randomization through 24 days after ICR initiation. Tolerability will be measured by number of ICR days attended (out of the required 24 ICR days).
Measured: From enrollment, to completion of at least 24 cardiac rehabilitation days.
Secondary outcomes (9)
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in exercise performance in six minute walk test.
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in exercise performance in Short Performance Battery Test.
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in exercise performance in handgrip dynamometer test.
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in Patient Reported Outcomes (PROs): Cardiac Self-Efficacy Questionnaire.
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in Patient Reported Outcomes (PROs): Dartmouth COOP General Health Questionnaire
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in Patient Reported Outcomes (PROs): Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in Patient Reported Outcomes (PROs): Beck Depression Score (BDS)
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in Patient Reported Outcomes (PROs): Rate Your Plate (RYP)
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
To evaluate efficacy of early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge) in patients with HFrEF. Efficacy and tolerability will be assessed from baseline through completion of 24 ICR days:
- Changes in Patient Reported Outcomes (PROs): Duke Activity Status Index (DASI)
Measured: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 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 Washington University School of MedicineThe 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
- Model description
- Randomized, non-blinded parallel arm design.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda R Peterson, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858318
- Sponsor's protocol ID
- 202603003
- Other IDs
- GR0041819
- Acronym
- ACT-HF
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated (Intensive) Cardiac Training for Heart Failure Patients (ACT-HF)
- ClinicalTrials.gov ID
- NCT07858318
- Acronym / sponsor ID
- ACT-HF / 202603003
- Conditions
- Cardiac Rehabilitation, Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if patients undergoing accelerated Intensive Cardiac Rehabilitation (ICR) (2 weeks after discharge) will improve exercise performance as well as on measures of quality of life after a cardiac hospitalization.
Detailed description
The goal of this study is to evaluate the safety and effectiveness of initiating ICR (Intensive Cardiac Rehabilitation) at 2 weeks versus 6 weeks following hospital discharge in patients with HFrEF (Heart Failure with reduced Ejection Fraction). This is a randomized, controlled trial with two parallel groups. The Early Intervention Group with ICR initiated 2 weeks ±2 weeks following hospital discharge and the Usual Care Group with ICR initiated 6 weeks ±2 weeks after hospital discharge. Potential participants will be identified at Missouri Baptist Medical Center and referred for ICR at the HCI (Heart Care Institute) at Barnes Jewish West County Hospital (BJWCH). This study is being funded by the Missouri Baptist Healthcare Foundation.
To be evaluable, participants must complete a minimum of 24 ICR days, scheduled up to three days per week, with the option of completing a maximum of 36 ICR days over a period of up to 12-to-15-weeks post hospital discharge. The study team will analyze the ICR data from the start of ICR through 24 days of ICR. Data after 24 days will only include information on whether a participant continues to complete the maximum 36 days of ICR. During the trial, participants will complete performance tests and PRO (Participant Reported Outcome) surveys and questionnaires. Performance tests include a 6MWT (six minute walk test), a SPPB test (Short Performance Battery Test), and a handgrip test and will be completed at baseline, and the start of ICR and at the end of the completion of the 24th day of ICR.
PROs include a Cardiac Self-Efficacy Questionnaire (survey), Dartmouth COOP General Health Questionnaire (survey), PHQ-9 (survey), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Beck Depression Score (BDS), Rate Your Plate (RYP) and Duke Activity Status Index (DASI). PROs will be completed during baseline, start of ICR, and at the end of the 24th day of ICR.
The Early Intervention Group will repeat performance assessments and PROs 6-weeks (approximately 4-weeks post ICR start-up) following hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, non-blinded parallel arm design.
| Arm | Type | Receives |
|---|---|---|
| 2 weeks post discharge group | Active comparator | Other: Early ReferralParticipants will be randomized into a 2 week post discharge group that will start cardiac rehabilitation 2 weeks after discharge compared to normal SOC at 6 weeks post discharge. |
| 6 weeks post discharge group (SOC) | Placebo comparator | Other: Standard Of Care (SOC) + PlaceboParticipants will be randomized into the SOC 6 week post discharge group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years of age at the time of consent
- Diagnosis of HFrEF
- EF <35% within 3 months of hospital discharge
- Current hospitalization for a cardiac event (an approved cardiac diagnosis, such as chronic angina, recent MI (heart attack), cardiac surgery, or recent percutaneous coronary intervention (PCI) e.g., stent placement)
- Agreeable to complete 24 days of ICR and study requirements
Key exclusion criteria (7 listed)
- Diagnosis of dementia
- Significant orthopedic limitations (e.g., double amputee) (walking with a walker is acceptable)
- Discharge to rehab facility or nursing home
- Pregnant women
- Currently enrolled in Hospice, not expected to live for 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early ReferralPatients will be early referred (2 wks vs 6wks) to cardiac rehabilitation to see if there are benefits to early referral. | Other | 2 weeks post discharge group |
| Standard Of Care (SOC) + PlaceboNormal Standard of care 6 week referral time. | Other | 6 weeks post discharge group (SOC) |
Primary outcome
Safety and Tolerability of Accelerated ICR 2 weeks and 6 weeks post-hospital discharge
Time frame: From enrollment, to completion of at least 24 cardiac rehabilitation days.
To evaluate safety/tolerability of accelerated ICR beginning 2 weeks post-hospital discharge compared to usual standard care ICR beginning 6 weeks post-hospital discharge in patients with HFrEF. Safety will be determined by incidence of adverse events from randomization through 24 days after ICR initiation. Tolerability will be measured by number of ICR days attended (out of the required 24 ICR days).
9 secondary outcomes
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Efficacy of enrollment rates in Cardiac Rehabilitation
Time frame: From enrollment, to at least the completion of 24 cardiac rehabilitation days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda R Peterson, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Early Referral in people with Cardiac Rehabilitation and Heart Failure, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawson Haley A Haley, B.S. (314-362-8941, dhaley@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Accelerated ICR 2 weeks and 6 weeks post-hospital discharge (time frame: From enrollment, to completion of at least 24 cardiac rehabilitation days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.