Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure (OptimEx-Clin)

Technical University of Munich

Status: Completed

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Behavioral: Usual Care; Behavioral: High Intensity Exercise; Behavioral: Moderate Continuous Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02078947

EU 602405-2

Details and patient eligibility

About

Aim of the clinical multicenter study (OptimEx-CLIN) is to assess the optimal exercise intervention in patients with Heart Failure with preserved Ejection Fraction (HFpEF; also termed diastolic heart failure) that will best improve peak oxygen uptake (Peak Vo2) and additionally diastolic function (assessed echocardiographically). The investigators hypothesize that exercise training reverses HFpEF and that intensity of exercise training is more important than duration.

Enrollment: 180 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sedentary (structured exercise < 2x 30 min/wk)
• At least 40 years old
• Preserved systolic function LVEF > 50%
• Signs and symptoms of heart failure class NYHA II or III
• Diastolic dysfunction (E/é > 15 or E/é 8-15 and NT-proBNP > 220 pg/ml)
• Clinically stable for >= 6 weeks
• Optimal medical treatment for >= 6 weeks
• Written informed consent

Exclusion criteria

• Non- HFpEF causes for HF symptoms (significant valvular or coronary disease, uncontrolled hypertension or arrhythmias, primary cardiomyopathies)
• Significant pulmonary disease (FEV1 < 50% predicted, COPD GOLD III-IV)
• Inability to exercise or conditions that may interfere with exercise intervention
• Myocardial infarction in the previous three months
• Signs of ischemia during exercise testing
• Comorbidity that may influence one- year prognosis
• Participation in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

High Intensity Exercise

Experimental group

Description:

Patients perform interval- type endurance exercise at high intensity

Treatment:

Behavioral: High Intensity Exercise

Moderate Continuous Exercise

Active Comparator group

Description:

Patients perform endurance exercise at moderate intensity

Treatment:

Behavioral: Moderate Continuous Exercise

Usual Care

Sham Comparator group

Description:

Patients receive advice on being physically active as well as usual care

Treatment:

Behavioral: Usual Care