Accelerated (Intensive) Cardiac Training for Heart Failure Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Early Referral
Other interventionPatients will be early referred (2 wks vs 6wks) to cardiac rehabilitation to see if there are benefits to early referral.
Standard Of Care (SOC) + Placebo
Other interventionNormal Standard of care 6 week referral time.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: 2 weeks post discharge groupActive comparator 1 intervention
Group B: 6 weeks post discharge group (SOC)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
From enrollment, to completion of at least 24 cardiac rehabilitation days.Secondary outcomes
1
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.
Time frame
From enrollment, to at least the completion of 24 cardiac rehabilitation days.2
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.
Time frame
From enrollment, to at least the completion of 24 cardiac rehabilitation days.3
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.
Time frame
From enrollment, to at least the completion of 24 cardiac rehabilitation days.4
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.
Time frame
From enrollment, to at least the completion of 24 cardiac rehabilitation days.Other outcomes
1
Rehospitalization and All- Cause Morality within 6 Months Post-Hospital Discharge
To evaluate rehospitalization and all-cause mortality within 6 months post-hospital discharge for HFrEF patients enrolled in early ICR (2 weeks post-hospital discharge) compared to usual care ICR (6 weeks post-hospital discharge).I ncidence of rehospitalization and, all-cause mortality and deaths from randomization through the 6-month follow up phone call.
Time frame
Enrollment to within 6 months post-hospital dischargeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: