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

Completed

• Conditions: Heart Failure, Diastolic

• Registration Number: NCT05162859
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-17
• Study Start: 2021-12-20
• Primary Completion: 2022-08-19
• Study Completion: 2022-08-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy / breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in peak oxygen consumption (mL/kg/min)	From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)	Changes in Short Form-36 questionnaire (patients from Ex-DHF, scale 0-100, higher is better) and Kansas City Cardiomyopathy Questionaire - Quality of Life domain (patients from OptimEx, scale 0-100, higher is better) will be combined using the standardized mean difference
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 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 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 E/e'	From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Germany