SENSORFIT-4HEART: Smart Exercise preScriptiOn and Remote Monitoring FITness Platform for HEART Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Peak oxygen consumption
研究概览
简要总结
Heart failure with preserved ejection fraction (HFpEF) is a complex syndrome with increasing incidence and poor prognosis, accounting for up to 50% of heart failure cases. It is strongly associated with aging, cardiovascular risk factors (hypertension, diabetes, obesity), and is more prevalent in women than men. Patients with HFpEF frequently present with dyspnea, debilitating fatigue, poor quality of life, frequent hospitalizations, and high mortality rates. This study aims to evaluate the effects of a structured exercise program on cardiac function, skeletal muscle metabolism, functional capacity, and quality of life in patients with HFpEF, and to explore whether these benefits are mediated by circulating exerkines.
详细描述
Standard pharmacological treatments have shown limited prognostic benefit, highlighting the need for non-pharmacological strategies. Exercise training may represent an effective therapeutic tool, with potential to improve cardiac remodeling, skeletal muscle bioenergetics, exercise tolerance, and quality of life. Importantly, exerkines-molecules secreted by skeletal muscle and other organs in response to exercise-may mediate systemic beneficial effects by modulating metabolic, immuno-inflammatory, and growth pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.
- •Left ventricular ejection fraction (LVEF) >40%, and/or evidence of structural and/or functional cardiac abnormality (diastolic dysfunction, elevated filling pressures, BMI>30 kg/m2)
- •Elevated natriuretic peptides (BNP ≥35 pg/mL or NT-proBNP ≥125 pg/mL)
- •Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month
排除标准
- •Participation in cardiac rehabilitation within the past 12 months.
- •Contraindications to physical exercise training.
- •Alternative diagnoses that could explain symptoms of HF (dyspnea, fatigue), in the judgment of the cardiologist.
- •Significant pulmonary disease, including primary pulmonary hypertension.
- •Severe chronic lung disease, including COPD requiring home oxygen, chronic nebulizer therapy, long-term oral steroids, or hospitalization for decompensated pulmonary disease within the past 12 months.
- •Hemoglobin <10 g/dL.
- •Body mass index (BMI) >40 kg/m².
- •Inability to perform a valid baseline cardiopulmonary exercise test
- •Inability to comprehend study information or complete questionnaires (e.g., psychiatric disorder, dementia).
结局指标
主要结局
Peak oxygen consumption
时间窗: Baseline and 12-week
Changes in peak oxygen consumption between and within groups at 12-week Unit of measure of peak oxygen consumption: mL/kg/min. Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 25 W and increasing gradually in a ramp protocol at 25-W increments every 3 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was \>1. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) was defined as the highest value of VO2 during the last 20 seconds of exercise.
次要结局
- Lean mass (kg)(Baseline and 12-week)
- Changes in blood pressure(Baseline and 12-week)
- Changes in Heart rate(Baseline and 12-week)
- Changes in muscle strength(Baseline and 12-week)
- Changes in quality of life(Baseline and 12-week)
- Physical activity and sedentary behaviour (in minutes)(Baseline and 12-week)
- Pittsburgh Sleep Quality Index(Baseline and 12-week)
- Epidemiological Studies-Depression Scale questionnaire(Baseline and 12-week)
- Cognitive Function(Baseline and 12-week)
- Adherence to the Mediterranean Diet(Baseline and 12-week)
- Haematology(Baseline and 12-week)
- Psychological Distress(Baseline and 12-week)
- N-terminal pro-B-type natriuretic peptide (NT-proBNP)(Baseline and 12-week)
- Lean mass index (kg/m2)(Baseline and 12-week)
- Appendicular lean mass index (kg/m2)(Baseline and 12-week)
- Fat mass index (kg/m2)(Baseline and 12-week)
- Fat mass (kg)(Baseline and 12-week)
- Visceral adipose tissue (kg)(Baseline and 12-week)
- Lean mass/fat mass ratio(Baseline and 12-week)
- Fat free mass(Baseline and 12-week)
- Whole bone mineral density (g/cm2)(Baseline and 12-week)
- Concentrations of circulating cytokines, adipokines, myokines, and bone metabolism biomarkers.(Baseline and 12-week)
- Resting energy expenditure(Baseline and 12-week)
研究者
Dr Mikel Izquierdo
Principal Investigator
Universidad Pública de Navarra