Exercise Training in Heart Failure With Preserved Ejection Fraction - a Long-term Follow-up

Technical University of Munich1 site in 1 country74 target enrollmentDecember 20, 2021

ConditionsHeart Failure, Diastolic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure, Diastolic
Sponsor: Technical University of Munich
Enrollment: 74
Locations: 1
Primary Endpoint: Change in peak oxygen consumption (mL/kg/min)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Exercise training is an effective therapy for patients with heart failure with preserved ejection fraction. However, it is unclear, whether a one-year intervention has a sustainable effect beyond the active study phase. Hence, this study is a long-term follow-up of patients that were recruited for the OptimEx-Clin and Ex-DHF trials in Munich.

Registry

clinicaltrials.gov

Start Date

December 20, 2021

End Date

August 19, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Technical University of Munich

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients that were previously randomized to OptimEx-Clin or Ex-DHF in Munich
•Written informed consent

Exclusion Criteria

•Pregnancy / breastfeeding

Outcomes

Primary Outcomes

Change in peak oxygen consumption (mL/kg/min)

Time Frame: From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)

Secondary Outcomes

Change in quality of life(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))
Time to first cardiovascular event(From Last Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 3.3 to 8.2 years))
Change in left ventricular ejection fraction (%)(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))
Change in ventilation-to-carbon-dioxide production slope(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))
Change in oxygen consumption at the first ventilatory threshold (mL/kg/min)(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))
Change in E/e'(From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years))