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

NCT ID: NCT05162859

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2022-08-19

Brief Summary

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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

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Conditions

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Heart Failure, Diastolic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Former Exercise Training

Patients that were randomized to high-intensity-interval training, moderate continuous training (OptimEx-Clin) or moderate continuous training + resistance training (Ex-DHF)

No interventions assigned to this group

Former Control

Patients that were randomized to guideline control (OptimEx-Clin) or usual care (Ex-DHF)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy / breastfeeding
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabel Fegers-Wustrow, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, Technical University of Munich

Stephan Mueller

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, Technical University of Munich

Locations

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Klinikum rechts der Isar

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 33560320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25354950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28516519 (View on PubMed)

Other Identifiers

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627/21 S

Identifier Type: -

Identifier Source: org_study_id

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