Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure

N/ACompletedNCT02078947

Technical University of Munich180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Heart Failure With Preserved Ejection Fraction

Interventions

High Intensity ExerciseBEHAVIORAL

Moderate Continuous ExerciseBEHAVIORAL

Usual CareBEHAVIORAL

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (4)

Department of Cardiology, Antwerp University Hospital

Edegem, Belgium

Charité - Universitätsmedizin Berlin

Berlin, Germany

Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik

Leipzig, Germany

Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München

Munich, Germany

Outcomes

Primary Outcomes

Change in Peak VO2 after three months

Change in Peak VO2 after three month intervention

Time frame: Baseline and three months

Secondary Outcomes

Change in E/e' (representing diastolic filling pressure) at baseline and three months

Time frame: three months

Change in E/e' at baseline and 12 months

Time frame: 12 months

Change in Peak VO2 at baseline and 12 months

Time frame: 12 months

Change in NTproBNP at baseline and three months

Time frame: three months

Change in NTproBNP at baseline and 12 months

Time frame: 12 months

Change in health related quality of life at baseline and three months

Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and three months

Time frame: three months

Change in health related Quality of life at baseline and 12 months

Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and 12 months

Data from ClinicalTrials.gov

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