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Universidad StanfordREHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06150950 es un ensayo intervencionista para Insuficiencia cardíaca congénita, Ventrículo único. Su estado actual es: reclutando. El ensayo se inició el 5 de mayo de 2024, con el objetivo de reclutar a 50 participantes. Dirigido por la Universidad Stanford, se espera que finalice el 31 de diciembre de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 7 de mayo de 2024.
Resumen
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?
Descripción detallada
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.
Título oficial
RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure
Condiciones médicas
Insuficiencia cardíaca congénitaVentrículo únicoOtros ID del ensayo
- 67788
Número del NCT
Inicio del ensayo (real)
2024-05-05
Última actualización
2024-05-07
Fecha de finalización (estimada)
2025-12-31
Inscripción (prevista)
50
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
Fontan
Single ventricle
Cardiac rehabilitation
Single ventricle
Cardiac rehabilitation
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalCardiac rehabilitation 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. | Rehabilitación cardíaca 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. |
Comparador activoUsual care 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. | Cuidado habitual 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. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Average daily step count | Average daily step count during the intervention period measured by Fitbit 3 activity tracker | 120 days (+/- 45 days) post-randomization |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in 5-meter timed walk as a measure of slowness | Baseline and 120 days (+/- 45 days) post-randomization | |
Change in exercise time as a measure of exhaustion | Exercise time on cardiopulmonary exercise testing | 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) | 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 | Baseline and 120 days (+/- 45 days) post-randomization |
Change in body fat percentage | Body fat percentage is a measure of body composition | Baseline and 120 days (+/- 45 days) post-randomization |
Change in grip strength | 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. | 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. | 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) | Baseline and 120 days (+/- 45 days) post-randomization |
Average daily active minutes | Total average daily active minutes from Fitbit | 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 | Baseline and 120 days (+/- 45 days) post-randomization |
Average daily sedentary minutes | Average daily sedentary minutes from Fitbit | 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 | Baseline and 120 days (+/- 45 days) post-randomization |
Change in oxygen (O2) pulse | O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline | 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 | Baseline and 120 days (+/- 45 days) post-randomization |
Change in anaerobic threshold | Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline | Baseline and 120 days (+/- 45 days) post-randomization |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- 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
- 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%
Universidad Stanford671 ensayos clínicos activos para explorar
Universidad Vanderbilt352 ensayos clínicos activos para explorar- 🏛️Adult Congenital Heart Association
- 🏛️Julie Fletcher Memorial Fund
- 🏛️Pete Huttlinger Memorial Fund
Parte responsable del ensayo
Daniel Clark, Investigador principal, Assistant Professor of Adult and Pediatric Cardiology, Stanford University
No hay datos de contacto.
2 Sitios del ensayo en 1 países
California
Stanford University, Stanford, California, 94305, United States
DANIEL CLARK, MD, MPH, Contacto, 650-724-9220, [email protected]
Reclutando
Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37240, United States
Jonathan Menachem, MD, Contacto, 615-322-2318, "Jonathan Menachem" <[email protected]>
Reclutando