Clinical trial NCT05162859: Exercise Training in Heart Failure With Preserved Ejection Fraction - a Long-term Follow-up
Official title: Exercise Training in Heart Failure With Preserved Ejection Fraction - a Long-term Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Diastolic
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure with preserved ejection fraction that were included in previous exercise intervention trials in Munich, Germany (OptimEx-Clin, NCT02078947; Ex-DHF, ISRCTN86879094)

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy / breastfeeding

Primary outcomes:
measure: Change in peak oxygen consumption (mL/kg/min)
timeFrame: From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)
Secondary outcomes:
measure: Change in oxygen consumption at the first ventilatory threshold (mL/kg/min)
timeFrame: From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)
measure: Change in ventilation-to-carbon-dioxide production slope
timeFrame: From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)
measure: Change in E/e'
timeFrame: From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)
measure: Change in left ventricular ejection fraction (%)
timeFrame: From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)
measure: Change in quality of life
timeFrame: From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years)
measure: Time to first cardiovascular event
timeFrame: From Last Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 3.3 to 8.2 years)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
Study officials:
affiliation: Klinikum rechts der Isar, Technical University of Munich
name: Isabel Fegers-Wustrow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar, Technical University of Munich
name: Stephan Mueller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller S, Winzer EB, Duvinage A, Gevaert AB, Edelmann F, Haller B, Pieske-Kraigher E, Beckers P, Bobenko A, Hommel J, Van de Heyning CM, Esefeld K, von Korn P, Christle JW, Haykowsky MJ, Linke A, Wisloff U, Adams V, Pieske B, van Craenenbroeck EM, Halle M; OptimEx-Clin Study Group. Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2021 Feb 9;325(6):542-551. doi: 10.1001/jama.2020.26812.
citation: Suchy C, Massen L, Rognmo O, Van Craenenbroeck EM, Beckers P, Kraigher-Krainer E, Linke A, Adams V, Wisloff U, Pieske B, Halle M. Optimising exercise training in prevention and treatment of diastolic heart failure (OptimEx-CLIN): rationale and design of a prospective, randomised, controlled trial. Eur J Prev Cardiol. 2014 Nov;21(2 Suppl):18-25. doi: 10.1177/2047487314552764.
citation: Edelmann F, Bobenko A, Gelbrich G, Hasenfuss G, Herrmann-Lingen C, Duvinage A, Schwarz S, Mende M, Prettin C, Trippel T, Lindhorst R, Morris D, Pieske-Kraigher E, Nolte K, Dungen HD, Wachter R, Halle M, Pieske B. Exercise training in Diastolic Heart Failure (Ex-DHF): rationale and design of a multicentre, prospective, randomized, controlled, parallel group trial. Eur J Heart Fail. 2017 Aug;19(8):1067-1074. doi: 10.1002/ejhf.862. Epub 2017 May 17.