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Lo studio clinico NCT07223242 (TEXPEF) per HFpEF - Insufficienza cardiaca con frazione di eiezione preservata, Cardiomiopatie diabetiche è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Centro Medico Surocdental dell'Università del TexasTailored Exercise Training Study Among Adults With HFpEF (TEXPEF)
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La sperimentazione clinica NCT07223242 (TEXPEF) è uno studio interventistico di Fase II Fase III volto a esaminare il trattamento per HFpEF - Insufficienza cardiaca con frazione di eiezione preservata, Cardiomiopatie diabetiche, attualmente in arruolamento. Avviato il 18 febbraio 2025, prevede di arruolare 120 partecipanti. Sotto la guida di il Centro Medico Surocdental dell'Università del Texas, dovrebbe concludersi entro il 30 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 31 ottobre 2025.
Sommario breve
Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.
Descrizione dettagliata
Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. It is now recognized as a systemic, multi-organ, geriatric syndrome, with exercise intolerance (EI) and functional impairment as the key clinical manifestations. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare the effects of four different lifestyle interventions on exercise capacity.
The study will be carried out in two phases. In Phase I, 120 participants will undergo three months of home-based moderate-intensity continuous training (MCT), using tailored exercise videos on a mobile or tablet. Participants will also have weekly virtual meetings with a coach to discuss their progress. This will be followed by 3 months of no intervention, to assess the effects of detraining.
In Phase II (at the 6-month mark), 100 participants will be randomized to one of four extended training strategies for 3 months -(i) MCT alone; (ii) MCT plus resistance training; (iii) MCT plus weight loss, or (iv) MCT plus resistance training and weight loss.
The co-primary outcomes are (1) peak VO2, and (2) short physical performance battery score. In addition, participants will undergo CT chest/abdomen/pelvis at 3 months and 6 months to assess change in skeletal muscle composition with MCT
Titolo ufficiale
Tailored Exercise Training Study Among Adults With HFpEF
Condizioni
HFpEF - Insufficienza cardiaca con frazione di eiezione preservataCardiomiopatie diabeticheAltri ID dello studio
- TEXPEF
- STU-2024-0592
Numero NCT
Data di inizio (effettiva)
2025-02-18
Ultimo aggiornamento pubblicato
2025-10-31
Data di completamento (stimata)
2026-12-30
Arruolamento (previsto)
120
Tipo di studio
Interventistico
FASE
Fase II
Fase III
Fase III
Stato
In arruolamento
Parole chiave
Diabetic cardiomyopathy
Remote exercise training
Weight loss
Rehab
Remote exercise training
Weight loss
Rehab
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivoModerate-intensity continuous training (MCT) Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach | Moderate-intensity Continuous Training (MCT) Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach |
SperimentaleModerate-intensity continuous training + weight loss Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + initiation/intensification of pharmacological weight loss | Moderate-intensity Continuous Training (MCT) Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach Perdita di peso Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide |
SperimentaleModerate-intensity continuous training + resistance training Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos | Moderate-intensity Continuous Training (MCT) Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach Allenamento di resistenza Resistance training videos assigned to patient |
SperimentaleModerate-intensity continuous training + resistance training + weight loss Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss | Moderate-intensity Continuous Training (MCT) Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach Allenamento di resistenza Resistance training videos assigned to patient Perdita di peso Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Peak Exercise Oxygen Uptake (VO2peak) | VO2peak indexed to body weight (mL/kg/min) will be the co-primary outcome for the trial. VO2peak is a gold-standard measure of aerobic exercise capacity and will be measured by maximal exercise test using a previously established ergometer protocol | Baseline, 3months, 6months, and 9months |
Short Physical Performance Battery (SPPB) | SPPB will be a co-primary outcome for the trial. Score ranges from 0 to 12, with 0 indicating the worst performance and 12 indicating the best. | Baseline, 3months, 6months, and 9months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) | Health-related quality of life will be assessed using the KCCQ-12 questionnaire. This is a self-administered questionnaire that assesses a patient's perception of their heart failure with regard to the psychological, physical, and socioeconomic aspects of life. Scores range from 0 to 100, where 0 indicates the worst possible health status and 100 indicates the best. | Baseline, 3months, 6months, and 9months |
6 Minute Walk Distance (6MWD) | 6MWD is a simple and well-validated measure of submaximal exercise capacity and does not require any exercise equipment or advanced training for technicians | Baseline, 3months, 6months, and 9months |
General Quality of Life - EQ-5D-5L | Change in general health-related quality of life assessed using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) instrument. The EQ-5D-5L uses a descriptive system to measure health-related quality of life across five key dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity-ranging from no problems (Level 1) to extreme problems or inability to function (Level 5). A respondent's answers generate a five-digit health state profile that reflects their unique combination of responses (e.g., 12345), representing one of 3,125 possible health states. This descriptive system enables consistent and standardized assessment of an individual's health status. | Baseline, 3months, 6months, and 9months |
Thirty Second Chair Test | The 30-second chair stand test measures lower-body strength and endurance by counting how many times a person can stand up from a chair and sit down within 30 seconds. | Baseline, 3months, 6months, and 9months |
Fried Frailty Phenotype | The Fried frailty phenotype defines frailty based on five criteria-unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Each criterion met adds one point to the total score. The Fried Frailty scale has a score range of 0 to 5. A score of 0 means the person is robust or not frail, a score of 1 or 2 indicates pre-frailty (intermediate risk), and a score of 3 or more means the person is considered frail. | Baseline, 3months, 6months, and 9months |
Resting cardiac output | Assess with echocardiography to measure stroke volume and heart rate during rest | Baseline, 3months, 6months, and 9months |
Exercise cardiac output | Assess with echocardiography to measure stroke volume and heart rate responses with graded physical stress. | Baseline, 3months, 6months, and 9months |
Intramyocellular fat | Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans will be used to measure the radiodensity of muscle tissue, quantified in Hounsfield Units (HU). Skeletal muscle tissue is assigned a range of HU values (-29 to +150). Higher fat content lowers the overall muscle density, resulting in lower HU values | Baseline, 3months, 6months, and 9months |
Intermuscular Adipose Tissue (IMAT) | Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify intermuscular adipose tissue (IMAT) using the Hounsfield unit (HU) scale, where IMAT is classified as fat density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm\^2) | Baseline, 3months, 6months, and 9months |
Subcutaneous adiposity deposits | Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify fat deposits using the Hounsfield unit (HU) scale, where fat is defined as a density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm\^2) | Baseline, 3months, 6months, and 9months |
Visceral Adiposity Deposits | Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify fat deposits using the Hounsfield unit (HU) scale, where fat is defined as a density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm\^2) | Baseline, 3months, 6months, and 9months |
Pericardial Adiposity Deposits | Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify fat deposits using the Hounsfield unit (HU) scale, where fat is defined as a density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm\^2) | Baseline, 3months, 6months, and 9months |
Lower Body Adiposity Deposits | Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify fat deposits using the Hounsfield unit (HU) scale, where fat is defined as a density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm\^2) | Baseline, 3months, 6months, and 9months |
E/e': Ratio of early mitral inflow velocity (E) to early diastolic mitral annular velocity (e') | Exercise echocardiography to measure E/e' ratio to assess left ventricular filling pressures at rest and during graded physical stress | Baseline, 3months, 6months, and 9months |
Left atrial reservoir strain | Assessed using echocardiography at rest and during graded physical stress | Baseline, 3months, 6months, and 9months |
Left ventricular global longitudinal strain (LV GLS) | Assessed using echocardiography at rest and during graded physical stress | Baseline, 3months, 6months, and 9months |
GAD 7 score | Change in anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. | Baseline, 3months, 6months, and 9months |
PHQ 9 score | This is a self-administered questionnaire that assesses the severity of depressive symptoms. The PHQ-9 (Patient Health Questionnaire-9) ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. | Baseline, 3months, 6months, and 9months |
NT-proBNP | Serum level of NT-proBNP (N-terminal pro-brain natriuretic peptide), a biomarker that reflects cardiac stress. | Baseline, 3months, 6months, and 9months |
High-sensitivity troponin I | Serum high-sensitivity troponin I reflects ongoing low-grade myocardial injury and is a marker of disease severity and prognosis in chronic heart failure. | Baseline, 3months, 6months, and 9months |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Age>= 18 yrs
LVEF (Left Ventricular Ejection Fraction) >= 50%
History of HFpEF or at risk of HFpEF
HFpEF diagnosis based on:- -HF hospitalization within 12 months-
- NT-proBNP >360 pg/mL
Risk of HFpEF based on:-
- >2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report)
SPPB < 10 or VO2<60th percentile
BMI >=28 (for randomization in phase II)
Able to use cell phone and mobile application
- Hospitalization 1 month prior to baseline visit
- History of recurrent falls
- eGFR (Estimated Glomerular Filtration Rate) <20ml/min/1.73m
- Active changes in HF therapies over 2 weeks prior to baseline visit
- Inability participate in exercise training therapy
- Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
- Severe left side valvular heart disease
- End stage pulmonary disease, requiring continuous supplemental oxygen
- Major surgery within 3 months of screening or major elective surgery during the duration of the study.
- Unstable weight defined by >5% change in body weight in last 30 days before first study visit.
- Pregnancy
Centro Medico Surocdental dell'Università del Texas285 studi clinici attivi da esplorareParte responsabile dello studio
Ambarish Pandey, Investigatore principale, Associate Professor of Medicine, University of Texas Southwestern Medical Center
Nessun dato di contatto
1 Centri dello studio in 1 paesi
Texas
University of Texas Southwestern Medical Center, Dallas, Texas, 75209, United States
Ambarish Pandey, MD, Contatto, 214-645-9868, [email protected]
In arruolamento