Heart failure with preserved ejection fraction, type 2 diabetes mellitus
Conditions
Interventions
Moderate-intensity exercise training
Moderate-intensity exercise training
Sponsors
National University Corporation Tsukuba University of Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: New York Heart Association (NYHA) functional classification 2 to 3 Heart failure with preserved ejection fraction Clinical symptoms of heart failure Left ventricular ejection fraction>50% Left ventricular diastolic dysfunction as defined by the American Society of Echocardiography/European Association of Cardiovascular Imaging HFA-PEFF score >5 points Type 2 diabetes mellitus Fasting plasma glucose level was >126 mg/dL 2 h value for the 75 g oral glucose tolerance test was >200 mg/dL Causal plasma glucose level was > 200 mg/dL Hemoglobin A1c level > 6.5%
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in peak oxygen uptake, and 6-minute walk distance from baseline following exercise training intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of a composite endpoint of heart failure-related readmission or all-cause mortality after the end of the 5-month exercise-training intervention. | — |
Countries
Japan
Contacts
Public ContactYousuke Sugita
National University Corporation Tsukuba University of Technology Faculty of Health Sciences
Outcome results
None listed