Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Preserved Ejection Function and Chronotropic Incompetence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Peak oxygen consumption
研究概览
简要总结
This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Patients with heart failure with preserved ejection fraction, functional class NYHA II-III, and chronotropic incompetence criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 80 patients (20 per arm) would be necessary to test our hypothesis.
详细描述
Heart failure with preserved ejection fraction (HFpEF) is a highly prevalent clinical entity that predominantly affects women >60 years old, whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology. Chronotropic incompetence (CrI) has emerged as a crucial mechanism, particularly in patients older than 60 years, and is associated with more significant functional impairment. Supervised training programs in patients with heart failure and reduced ejection fraction and CrI have improved functional capacity and chronotropic response. However, we do not have evidence about the effects of a supervised training program on patients with HFpEF and CrI. This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HFpEF and CrI on peak oxygen consumption (peakVO2) and chronotropic response.
This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Patients with HFpEF, functional class NYHA II-III, and CrI criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 80 patients (20 per arm) would be necessary to test our hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Blinded only for the evaluator of primary and secondary endpoints
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.
- •N-terminal pro-B-type natriuretic peptide (NT-proBNP) >125 pg/mL in the last month
- •Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month
- •Age ≥ 60 years old.
- •Blunted heart rate (HR) response during a maximal cardiopulmonary exercise testing (CPET), defined as a chronotropic index <0.62 if previous treatment with Beta-blockers or chronotropic index <0.80 in patients without beta-blockers. Chronotropic index= [HRpeak exercise - HRrest] / [220 - age - HRrest]
排除标准
- •Inability to perform a valid baseline cardiopulmonary exercise test
- •Cardiac pacemaker
- •Significant primary moderate-to-severe valve disease
- •Effort angina or signs of ischemia during CPET
- •Primary cardiomyopathies
- •Cardiac transplantation
- •Any other comorbidity with a life expectancy of less than one year
研究组 & 干预措施
Usual care
Patients allocated to this arm will receive the usual care plus explicit recommendations for home-based aerobic and strength training.
Supervised aerobic training
Patients allocated to this arm will receive the usual care plus supervised aerobic training
干预措施: Supervised aerobic training (Behavioral)
Supervised aerobic plus low to moderate-intensity strenght training
Patients allocated to this arm will receive the usual care plus supervised aerobic and low to moderate-intensity strength training
干预措施: Supervised aerobic training (Behavioral)
Supervised aerobic plus low to moderate-intensity strenght training
Patients allocated to this arm will receive the usual care plus supervised aerobic and low to moderate-intensity strength training
干预措施: Supervised aerobic plus low to moderate-intensity strength training (Behavioral)
Supervised aerobic plus moderate to high-intensity strenght training
Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training.
干预措施: Supervised aerobic training (Behavioral)
Supervised aerobic plus moderate to high-intensity strenght training
Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training.
干预措施: Supervised aerobic plus moderate to high-intensity strength training (Behavioral)
结局指标
主要结局
Peak oxygen consumption
时间窗: Peak oxygen consumption will be evaluated at first visit and after 3 months. We will evaluate peak oxygen consumption change from baseline.
Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 10 W and increasing gradually in a ramp protocol at 10-W increments every 1 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was \>1. During exercise, patients will be monitored with 12-lead electrocardiogram and blood pressure measurements every 2 minutes. 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. Primary outcome: changes in peak oxygen consumption between and within groups at 12-week Unit of measure of peak oxygen consumption: mL/kg/min
次要结局
- Chronotropic response(Chronotropic index will be evaluated at first visit and after 3 months. We will evaluate chronotropic index change from baseline.)
- Kansas City Cardiomyopathy Questionnaire Scales(The Kansas City Cardiomyopathy Questionnaire will be evaluated at first visit and after 3 months. We will evaluate the Kansas City Cardiomyopathy Questionnaire change from baseline.)