Clinical trial NCT03245125: HIIT Improves Survival of Heart Failure Patients
Official title: Impacts of High-intensity Interval Training on Long-term Survival of Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiac Rehabilitation
Cardiac Remodeling, Ventricular
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2017-08-10
Enrollment: 329
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Baseline information of all eligible candidates, including age, gender, body mass index (BMI), and disease duration were recorded. Serum low-density lipoprotein (LDL), creatinine (Cre), high sensitivity C-reactive protein (hs-CRP), glycohemoglobin (Hba1c), and b-type natriuretic peptide (BNP) were evaluated during the follow-up. Each blood sampling for BNP analysis and short form-36 health survey (SF-36) of physical component score (PCS) and mental component score (MCS) for qualities of life were performed just before each cardiopulmonary exercise test and echocardiographic examination.

Brief summary: BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies. High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF patients, which was hypothesized to improve the survival of HF patients.

OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of HF patients.

METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF patients with LVEF\> 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up. Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF during at end of the study.


Eligibility criteria: Inclusion Criteria:

From January 1st, 2009 to December 31st, 2016, HF patients, defined according to the European society of cardiology, with stable clinical status greater than 4 weeks after optimal treatment were enrolled in the study.

Exclusion Criteria:

Those, who were ≥ 80 years and \< 20 years, unable to perform exercise caused by other non-cardiac disease, pregnant, future cardiac transplantation within 6 months, uncompensated HF patients, pacemaker patients, and renal patients with estimated glomerular filtration rate \< 30 ml/min/1.73m2, were not candidates in the study. Patients had absolute contraindications for cardiopulmonary exercise test (CPET) and aerobic activities, suggested by the American College of Sports Medicine (ACSM), were also excluded in the study.

Primary outcomes:
measure: all-cause death
timeFrame: 2009/1/1 to 2016/12/31
measure: all-cause re-admission
timeFrame: 2009/1/1 to 2016/12/31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of PM&R, Keelung Chang Gung Memorial Hospital
name: Chih-Chin Hsu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fu TC, Wang CH, Lin PS, Hsu CC, Cherng WJ, Huang SC, Liu MH, Chiang CL, Wang JS. Aerobic interval training improves oxygen uptake efficiency by enhancing cerebral and muscular hemodynamics in patients with heart failure. Int J Cardiol. 2013 Jul 15;167(1):41-50. doi: 10.1016/j.ijcard.2011.11.086. Epub 2011 Dec 22.
citation: Lee MF, Chen WS, Fu TC, Liu MH, Wang JS, Hsu CC, Huang YY, Cherng WJ, Wang CH. Non-invasive cardiac index monitoring during cardiopulmonary functional testing provides additional prognostic value in patients after acute heart failure. Int Heart J. 2012;53(6):364-9. doi: 10.1536/ihj.53.364.