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OpenTrials
Completed

NCT Number: NCT05162859

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

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.

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Key information

Conditions

Heart Failure, Diastolic Cardiovascular Diseases Heart Diseases Heart Failure

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar

Munich, 80992, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy / breastfeeding

Treatment and study plan

Primary outcomes

  1. 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

  1. Change in oxygen consumption at the first ventilatory threshold (mL/kg/min)

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

  2. Change in ventilation-to-carbon-dioxide production slope

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

  3. Change in E/e'

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

  4. Change in left ventricular ejection fraction (%)

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

  5. Change in quality of life

    Time frame: 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

  6. Time to first cardiovascular event

    Time frame: From Last Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 3.3 to 8.2 years)

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2021
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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