Effect of cardiac rehabilitation on exercise capacity, left ventricular structure and function, and hemodynamics in patients with heart failure with preserved ejection fraction

UMIN ID: UMIN000045474

Registered date:13/09/2021

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Patients with heart failure with preserved ejection fraction
• Date of first enrollment: 2016/11/04
• Target sample size: 110
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Exercise training(Aerobic exercise, resistance training)
Normal treatment(only medication)

Outcome(s)

• Primary Outcome: Peak oxygen uptake (5 months after intervention)
• Secondary Outcome: 1.Echocardiography (E/e', LV-GLS, LAVI) 2.Brain natriuretic peptide 3.Ventilatory equivalent versus carbon dioxide output slope 4.6-minute walking distance 5.Composite endpoint of all-cause mortality or heart failure-related hospitalization 3 years after the end of the intervention period

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.Exacerbation of subjective symptoms of heart failure(dyspnea, fatigue, etc.) within the past week 2.Unstable angina or low threshold (induced by slow walking on level ground 2METs) myocardial ischemia 3.Severe valvular disease for which surgery is indicated, especially aortic stenosis 4.Severe left ventricular outflow tract stenosis (obstructive hypertrophic cardiomyopathy) 5.Untreated exercise-induced severe arrhythmia (ventricular fibrillation, persistent ventricular tachycardia) 6.Active myocarditis 7.Acute systemic disease or fever 8.Other diseases for which exercise therapy is contraindicated (moderate or higher aortic aneurysm, severe hypertension, thrombophlebitis, embolism within 2 weeks, serious other organ damage, etc.) 9.Patients with congenital cardiovascular disease 10.Renal failure with estimated glomerular filtration rate <30 11.Persons who have been diagnosed with psychiatric disorders 12.Malignant tumor 13.Persons who fall under the NYHA classification <New York Heart Association functional classification> grade I (patients with heart disease with no restrictions on physical activity) and grade IV (patients with heart disease who have symptoms in any physical activity) 14.65 years old or younger, 80 years old or older

Related Information

• Primary Sponsor: Tsukuba University of Technology
• Source(s) of Monetary Support: Tsukuba University of Technology
• Secondary ID(s): 2021-08