Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Diastolic heart failure, Heart failure with preserved ejection fraction, exercise
Brief summary
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.
Interventions
Sponsors
European Commission
University of Leipzig
University Hospital, Antwerp
Medical University of Graz
Norwegian University of Science and Technology
Charite University, Berlin, Germany
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak VO2 after three months | Baseline and three months | Change in Peak VO2 after three month intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in E/e' at baseline and 12 months | 12 months | Change in E/e' at baseline and 12 months |
| Change in Peak VO2 at baseline and 12 months | 12 months | Change in Peak VO2 at baseline and 12 months |
| Change in NTproBNP at baseline and three months | three months | Change in NTproBNP at baseline and three months |
| Change in NTproBNP at baseline and 12 months | 12 months | Change in NTproBNP at baseline and 12 months |
| Change in health related quality of life at baseline and three months | three months | Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and three months |
| Change in health related Quality of life at baseline and 12 months | 12 months | Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and 12 months |
| Change in Left Atrial Volume Index (LAVI) at baseline and three months | three months | Change in Left Atrial Volume Index (LAVI) at baseline and three months |
| Change in Left Atrial Volume Index (LAVI) at baseline and 12 months | 12 months | Change in Left Atrial Volume Index (LAVI) at baseline and 12 months |
| Change in E/e' (representing diastolic filling pressure) at baseline and three months | three months | Change in E/e' (representing diastolic filling pressure) at baseline and three months |
| Change in e' at baseline and 12 months | 12 months | Change in e' at baseline and 12 months |
| Change in submaximal exercise capacity at baseline and three months | three months | submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1) |
| Change in submaximal exercise capacity at baseline and 12 months | 12 months | Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1) |
| Change in VE/VCO2 slope at baseline and three months | three months | Change in VE/VCO2 slope at baseline and three months |
| Change in VE/VCO2 slope at baseline and 12 months | 12 months | Change in VE/VCO2 slope at baseline and 12 months |
| Change in Flow Mediated Dilation (FMD) at baseline and three months | three months | Change in Flow Mediated Dilation (FMD) at baseline and three months |
| Change in Flow Mediated Dilation (FMD) at baseline and 12 months | 12 months | Change in Flow Mediated Dilation (FMD) at baseline and 12 months |
| Change in e' medial at baseline and three months | three months | Change in e' medial at baseline and three months |
Countries
Belgium, Germany
Outcome results
None listed