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临床试验/NCT05487716
NCT05487716已完成不适用

Effects of High-Intensity Interval Training on Long-term Survival in Patients With Different Heart Failure Phenotypes

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
214
试验地点
1
主要终点
Mortality

研究概览

简要总结

The American Heart Association announces that exercise training should be considered for all stable cardiac patients (Class I, Level A). Therefore, exercise is an important issue for cardiac patients. It has also been reported that high-intensity interval training (HIIT) brings benefits on reversal of cardiac remodeling and long-term survival for HF patients. This study explores high-intensity interval training (HIIT) effects on long-term survivals in heart failure (HF) patients, diagnosed according to the Framingham criteria.

This retrospective cohort study is going to analyze HF patients diagnosed between January 1, 2009 and May 31, 2022 in a tertiary care hospital. All HF patients underwent the multidisciplinary disease management program (MDP) in the hospital were initially surveyed. Participants were further categorized into HF with reduced ejection fraction (HFrEF) (left ventricle ejection fraction [LVEF]<40%), HF with mildly reduced EF (HFmrEF) (LVEF>=40% and LVEF< 50%), and HF with preserved EF (HFpEF) ( LVEF>=50%) based on the initial 2-D echocardiography. Participants will be further divided into HIIT+MDP or MDP only in each group based on patient preference.

Age, sex, body height, body weight, disease duration, etiology for HF, co-morbidities, and medication were documented during follow-up (F/U). B-type natriuretic peptide, natriuretic peptide (BNP), cardiopulmonary exercise test (CPET) for peak oxygen consumption (VO2peak) and 2-D echocardiography for LV geometry were repeatedly assessed during follow-up. The end-point is the death of the patients or the date of May 31, 2022. All mortality causes and overall survival rates will be determined at the end of F/U.

HIIT effects on long-term survival (Kaplan-Meier survival curve) for patients with different heart failure phenotypes will be estimated by log rank test. Continuous variables between different groups were analyzed by student t-test, while continuous variables before and after HIIT within groups were assessed by paired t-test. Other non-continuous variables such as sex, and co-morbidities were compared by chi-square test.

详细描述

METHODS Participants The institutional review board of a tertiary care hospital approved the retrospective cohort study protocol. Patients with cardiovascular events between 1 January 2009 and 31 May 2022 in a tertiary care hospital and the following criteria were included.

  • Patients with a diagnosis of HF according to the Framingham HF diagnostic criteria.
  • HF patients with stable clinical presentation for> 4 weeks.

All included subjects received individualized patient education under optimized guideline-based management, i.e., multi-disciplinary disease management program (MDP), by the HF care team. Investigators excluded individuals based on the following criteria

  • Age < 20 years and > 80 years.
  • Pregnancy.
  • Chance of cardiac transplantation within 6 months
  • Moderate to severe chronic obstructive pulmonary disease
  • Uncompensated HF.
  • Estimated glomerular filtration rate < 30 ml/min/1.73m2
  • Absolute contraindications for exercise suggested by the American College of Sports Medicine.
  • Unable to perform exercise caused by non-cardiac disease.

Clinical Assessment Investigators recorded baseline age, sex, body mass index, co-morbidities, serum b-type natriuretic peptide levels, incremental cardiopulmonary exercise test (CPET) findings, and 2-D echocardiography measurements in all included participants. The physical component score (PCS) and mental component score (MCS) of the Medical Outcomes Study 36-item Short Form were used to evaluate quality of life (QoL) before initiating CPET.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of heart failure according to the Framingham HF diagnostic criteria
  • Stable heart failure clinical presentation for > 4 weeks.

排除标准

  • Pregnancy
  • Chance of cardiac transplantation within 6 months
  • Moderate to severe chronic obstructive pulmonary disease
  • Uncompensated heart failure
  • Estimated glomerular filtration rate < 30 ml/min/1.73m^2
  • Absolute contraindications for exercise suggested by the American College of Sports Medicine
  • Unable to perform exercise caused by non-cardiac disease

结局指标

主要结局

Mortality

时间窗: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Death registration on our chart

次要结局

  • VO2peak in MET(From date of inclusion until 12-16 weeks after inclusion date)
  • VE-VCO2 slope in (mL/min)/(mL/min)(From date of inclusion until 12-16 weeks after inclusion date)
  • LVEF in %(through study completion, up to 12 years)
  • Da-vO2 in mL/dL(From date of inclusion until 12-16 weeks after inclusion date)
  • LVEDD in mm(through study completion, up to 12 years)
  • LVESD in mm(through study completion, up to 12 years)
  • COex in mL/min(From date of inclusion until 12-16 weeks after inclusion date)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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