Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure

Heart Failure With Preserved Ejection Fraction Clinical Trial

— OptimEx-Clin  

Official title:

Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure- Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078947
• Other study ID #: EU 602405-2
• Status: Completed
• Phase: N/A
• Start date: July 28, 2014
• Est. completion date: June 27, 2018

Study information

• Verified date: July 2019
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 27, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure, Diastolic

Intervention

Behavioral:
• High Intensity Exercise

• Moderate Continuous Exercise

• Usual Care

Locations

Country	Name	City	State
Belgium	Department of Cardiology, Antwerp University Hospital	Edegem
Germany	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

Sponsors (7)

Lead Sponsor	Collaborator
Technische Universität München	Charite University, Berlin, Germany, European Commission, Medical University of Graz, Norwegian University of Science and Technology, University Hospital, Antwerp, University of Leipzig

Countries where clinical trial is conducted

Belgium,  Germany, 

References & Publications (2)

Gevaert AB, Witvrouwen I, Van Craenenbroeck AH, Van Laere SJ, Boen JRA, Van de Heyning CM, Belyavskiy E, Mueller S, Winzer E, Duvinage A, Edelmann F, Beckers PJ, Heidbuchel H, Wisløff U, Pieske B, Adams V, Halle M, Van Craenenbroeck EM; OptimEx-Clin Study — View Citation

Mueller S, Haller B, Halle M; OptimEx-Clin Study Group. Effect of Training on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction-Reply. JAMA. 2021 Aug 24;326(8):772-773. doi: 10.1001/jama.2021.10061. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak VO2 after three months	Change in Peak VO2 after three month intervention	Baseline and three months
Secondary	Change in E/e' (representing diastolic filling pressure) at baseline and three months	Change in E/e' (representing diastolic filling pressure) at baseline and three months	three months
Secondary	Change in E/e' at baseline and 12 months	Change in E/e' at baseline and 12 months	12 months
Secondary	Change in Peak VO2 at baseline and 12 months	Change in Peak VO2 at baseline and 12 months	12 months
Secondary	Change in NTproBNP at baseline and three months	Change in NTproBNP at baseline and three months	three months
Secondary	Change in NTproBNP at baseline and 12 months	Change in NTproBNP at baseline and 12 months	12 months
Secondary	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	three months
Secondary	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	12 months
Secondary	Change in Left Atrial Volume Index (LAVI) at baseline and three months	Change in Left Atrial Volume Index (LAVI) at baseline and three months	three months
Secondary	Change in Left Atrial Volume Index (LAVI) at baseline and 12 months	Change in Left Atrial Volume Index (LAVI) at baseline and 12 months	12 months
Secondary	Change in e' medial at baseline and three months	Change in e' medial at baseline and three months	three months
Secondary	Change in e' at baseline and 12 months	Change in e' at baseline and 12 months	12 months
Secondary	Change in submaximal exercise capacity at baseline and three months	submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)	three months
Secondary	Change in submaximal exercise capacity at baseline and 12 months	Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)	12 months
Secondary	Change in VE/VCO2 slope at baseline and three months	Change in VE/VCO2 slope at baseline and three months	three months
Secondary	Change in VE/VCO2 slope at baseline and 12 months	Change in VE/VCO2 slope at baseline and 12 months	12 months
Secondary	Change in Flow Mediated Dilation (FMD) at baseline and three months	Change in Flow Mediated Dilation (FMD) at baseline and three months	three months
Secondary	Change in Flow Mediated Dilation (FMD) at baseline and 12 months	Change in Flow Mediated Dilation (FMD) at baseline and 12 months	12 months

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