Heart Failure CongenitalNCT06150950
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
A study testing Cardiac rehabilitation in people with Heart Failure Congenital and Single-ventricle, run by Stanford University at 2 sites in United States.
Trial summary
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Congenital, Single-ventricle
- What is being tested?
- Cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2024to 31 Dec 2026
- 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
- Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF <50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 < 50% predicted (by FRIEND equation)
- Age >= 18 years old
Who cannot join
- Inotrope-dependence
- Symptomatic, uncontrolled arrhythmias
- Pregnancy
- Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
- Inability to comply with the protocol
- Recent (<3 months) planned Fontan pathway percutaneous or surgical intervention
- Resting hypoxemia with baseline oxygen saturation <80%
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37240
Jonathan Menachem, MD, 615-322-2318, "Jonathan Menachem" <jonathan.n.menachem@vumc.org>
- Recruiting
Stanford University
Stanford, California, 94305
DANIEL CLARK, MD, MPH, 650-724-9220, danclark@stanford.edu
About this study
Official title: RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.
- Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?
- Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?
Read the detailed description
REHAB Fontan Failure is a a multi-center, non-blinded, randomized clinical trial evaluating the effect of cardiac rehabilitation compared to usual care on exercise tolerance among adults with Fontan failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical care.
- Conditions
- Heart Failure Congenital, Single-ventricle
- Being tested
- Cardiac rehabilitation, Usual care
- Keywords
- Fontan, Single ventricle, Cardiac rehabilitation
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationBehavioural
Cardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation <50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities.
Usual careOther
For participants randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation | Experimental | For patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking. Receives: Behavioral: Cardiac rehabilitation |
| Usual care | Active comparator | For patients randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily step count
Average daily step count during the intervention period measured by Fitbit 3 activity tracker
Measured: 120 days (+/- 45 days) post-randomization
Secondary outcomes (16)
Change in 5-meter timed walk as a measure of slowness
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in exercise time as a measure of exhaustion
Exercise time on cardiopulmonary exercise testing
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in respiratory exchange ratio (RER) as a measure of exhaustion
RER on cardiopulmonary exercise testing (exhaustion)
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in mini-nutritional assessment short form (MNA-SF) score
Nutrition score as measured by MNA-SF; range 0-14; malnourished 0-7, 8-11 at-risk, and 12-14 normal nutritional status
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in body fat percentage
Body fat percentage is a measure of body composition
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in grip strength
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in patient reported physical activity questionnaire score
The physical activity questionnaire score ranges from 0 - 10,000 kilo-calories/week, with higher scores representing higher physical activity.
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score
KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement.
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change Patient Health Questionnaire-2 (PHQ-2) score
Mood assessment (Range 0-6, higher score indicates higher risk of depression, >=3 suggestive of depression)
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Average daily active minutes
Total average daily active minutes from Fitbit
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Average daily active minutes of moderate-high intensity activity
Average daily active minutes of moderate-high intensity activity from Fitbit
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Average daily sedentary minutes
Average daily sedentary minutes from Fitbit
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in peak respiratory oxygen uptake (VO2)
Peak VO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in oxygen (O2) pulse
O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in minute ventilation/carbon dioxide production (VE/VCO2)
VE/VCO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Change in anaerobic threshold
Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline
Measured: Baseline and 120 days (+/- 45 days) post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start5 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure CongenitalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- At enrollment, participants will be randomized in a 1:1 ratio to cardiac rehabilitation or usual care using randomly permuted blocks of 2, 4, and 6. The randomization will be stratified by study site and time from Fontan palliation.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Adult Congenital Heart Association, Julie Fletcher Memorial Fund, Pete Huttlinger Memorial Fund
- Responsible party
- Principal investigator, Daniel Clark, Stanford University
- Investigators
- Daniel E Clark, MD, MPH, Principal investigator, Stanford UniversityJonathan N Menachem, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150950
- Sponsor's protocol ID
- 67788
- Status last verified
- Dec 2025
- First submitted
- 30 May 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
- ClinicalTrials.gov ID
- NCT06150950
- Acronym / sponsor ID
- 67788
- Conditions
- Heart Failure Congenital, Single-ventricle
- Keywords
- Fontan, Single ventricle, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Adult Congenital Heart Association, Julie Fletcher Memorial Fund, Pete Huttlinger Memorial Fund
- Study start
- 5 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Nov 2023 (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 goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.
- Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?
- Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?
Detailed description
REHAB Fontan Failure is a a multi-center, non-blinded, randomized clinical trial evaluating the effect of cardiac rehabilitation compared to usual care on exercise tolerance among adults with Fontan failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At enrollment, participants will be randomized in a 1:1 ratio to cardiac rehabilitation or usual care using randomly permuted blocks of 2, 4, and 6. The randomization will be stratified by study site and time from Fontan palliation.
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation | Experimental | Behavioral: Cardiac rehabilitationFor patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking. |
| Usual care | Active comparator | Other: Usual careFor patients randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF <50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 < 50% predicted (by FRIEND equation)
- Age >= 18 years old
Key exclusion criteria (7 listed)
- Inotrope-dependence
- Symptomatic, uncontrolled arrhythmias
- Pregnancy
- Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
- Inability to comply with the protocol
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 |
|---|---|---|
| Cardiac rehabilitationCardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation <50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities. | Behavioural | Cardiac rehabilitation |
| Usual careFor participants randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. | Other | Usual care |
Primary outcome
Average daily step count
Time frame: 120 days (+/- 45 days) post-randomization
Average daily step count during the intervention period measured by Fitbit 3 activity tracker
16 secondary outcomes
Change in 5-meter timed walk as a measure of slowness
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in exercise time as a measure of exhaustion
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in respiratory exchange ratio (RER) as a measure of exhaustion
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in mini-nutritional assessment short form (MNA-SF) score
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in body fat percentage
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in grip strength
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in patient reported physical activity questionnaire score
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change Patient Health Questionnaire-2 (PHQ-2) score
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Average daily active minutes
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Average daily active minutes of moderate-high intensity activity
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Average daily sedentary minutes
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in peak respiratory oxygen uptake (VO2)
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in oxygen (O2) pulse
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in minute ventilation/carbon dioxide production (VE/VCO2)
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
Change in anaerobic threshold
Time frame: Baseline and 120 days (+/- 45 days) post-randomization
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 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Vanderbilt University Medical Center
Nashville, United States
Daniel E Clark, MD, MPH principal investigator
Stanford University
Jonathan N Menachem, MD principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation in people with Heart Failure Congenital and Single-ventricle, run by Stanford University at 2 sites in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily step count (time frame: 120 days (+/- 45 days) post-randomization). 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 Jan 2026.