NCT04745013招募中不适用
A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Study to Compare the Clinical and Cost Efficacy of a New Hybrid Exercise Intervention PRIORITY Versus Usual Care
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 312
- 试验地点
- 3
- 主要终点
- Changes in cardiorespiratory fitness
研究概览
简要总结
In the PRIORITY study, we aim to provide the clinical evidence base for the use of a new hybrid exercise intervention, which includes remotely guided home-based exercise, as an accessible, clinical and cost-effective treatment to prevent the deleterious effects of sedentary aging on the heart and forestall the development and progression towards overt HFpEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women (HF stage A) aged > 30 yrs:
- •treated or untreated patients with hypertension (blood pressure 130/80 - 159/99 mmHg) AND/OR
- •Patients with prediabetes (impaired fasting glucose and/or insulin resistance) with either:
- •Fasting plasma glucose: 100 to 125 mg/dL (5.6-6.9 mmol/L) Hemoglobine A1c: 5.7% to 6.4% Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index above 75% of population distribution (>2.0) AND/OR
- •Patients with obesity with 30 kg/m² ≥ body mass index ≤ 42 kg/m²
- •Patients with subclinical signs of diastolic dysfunction without symptoms (HF Stage B disease)
- •Men and women with diagnosis of HF stage C: i.e. patients who have a total score ≥ 5 points according to the recent recommendation paper on how to diagnose heart failure with preserved ejection fraction from the Heart failure Association of ESC.
- •All participants should be on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks before enrollment in the study. All participants should have internet access at home.
排除标准
- •significant illness during the last 6 weeks
- •known severe ventricular arrhythmia with functional or prognostic significance
- •significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
- •co-morbidity that may significantly negatively influence one-year prognosis
- •functional or mental disability that may limit execution of prescribed exercise
- •severe chronic obstructive pulmonary disease (FEV1 < 50%)
- •NYHA class IV
- •participation in another clinical interventional trial
- •cognitive limitation
结局指标
主要结局
Changes in cardiorespiratory fitness
时间窗: 1- and 2-year follow-up
Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion
次要结局
未报告次要终点
研究者
研究点 (3)
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