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治験 NCT07223242 (TEXPEF)（対象：HFpEF - 射出率保持型心不全、糖尿病性心筋症）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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テキサス大学南西部医学センターTailored Exercise Training Study Among Adults With HFpEF (TEXPEF)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07223242 (TEXPEF) は HFpEF - 射出率保持型心不全、糖尿病性心筋症 に関する 治療 の研究で、第II相・第二段階 第III相・第三段階 介入研究 臨床試験 です。現在は 募集中 で、2025年2月18日 から開始しています。120 名の参加者 の募集が計画されています。この治験は テキサス大学南西部医学センター によって主催され、2026年12月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年10月31日 です。
概要
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.
詳細説明
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
公式タイトル
Tailored Exercise Training Study Among Adults With HFpEF
疾患／病気
HFpEF - 射出率保持型心不全糖尿病性心筋症その他の研究識別子
- TEXPEF
- STU-2024-0592
NCT番号
開始日
2025-02-18
最終更新日
2025-10-31
終了予定日
2026-12-30
目標参加者数
120
試験の種類
介入研究
治験の相・段階
第II相・第二段階
第III相・第三段階
第III相・第三段階
状況
募集中
キーワード
Diabetic cardiomyopathy
Remote exercise training
Weight loss
Rehab
Remote exercise training
Weight loss
Rehab
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Moderate-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 |
実験的Moderate-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 体重減少 Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide |
実験的Moderate-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 レジスタンストレーニング Resistance training videos assigned to patient |
実験的Moderate-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 レジスタンストレーニング Resistance training videos assigned to patient 体重減少 Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
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
テキサス大学南西部医学センター285 件のアクティブな治験を探索責任者
Ambarish Pandey, 研究責任者, Associate Professor of Medicine, University of Texas Southwestern Medical Center
連絡先情報がありません。
1 1カ国の場所
Texas
University of Texas Southwestern Medical Center, Dallas, Texas, 75209, United States
Ambarish Pandey, MD, 連絡先, 214-645-9868, [email protected]
募集中