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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05162859

Enrollment

Registered

2021-12-17

Start date

2021-12-20

Completion date

2022-08-19

Last updated

2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Diastolic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Pregnancy / breastfeeding

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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 E/e'	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 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 left ventricular ejection fraction (%)	From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)	—

Countries

Germany

Outcome results