Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT02078947
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-05
• Study Start: 2014-07-28
• Primary Completion: 2017-09-30
• Study Completion: 2018-06-27
• Status Verified: 2019-07
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Peak VO2 after three months	Baseline and three months	Change in Peak VO2 after three month intervention

Secondary Outcome Measures

Name	Time	Method
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/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 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 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 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 e' medial at baseline and three months	three months	Change in e' medial at baseline and three months
Change in VE/VCO2 slope at baseline and three months	three months	Change in VE/VCO2 slope 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 Flow Mediated Dilation (FMD) at baseline and 12 months	12 months	Change in Flow Mediated Dilation (FMD) at baseline and 12 months

Trial Locations

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