NCT05162859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2022

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

November 11, 2021

Last Update Submit

January 10, 2024

Conditions

Heart Failure, Diastolic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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 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 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 quality of life

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

  • +1 more secondary outcomes

Study Arms (2)

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)

Former Control

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

You may not qualify if:

  • Pregnancy / breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, 80992, Germany

Location

Related Publications (3)

  • 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.

    PMID: 33560320BACKGROUND

  • 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.

    PMID: 25354950BACKGROUND

  • 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.

    PMID: 28516519BACKGROUND

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Isabel Fegers-Wustrow, MD

    Klinikum rechts der Isar, Technical University of Munich

    PRINCIPAL INVESTIGATOR

  • Stephan Mueller

    Klinikum rechts der Isar, Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2021

First Posted

December 17, 2021

Study Start

December 20, 2021

Primary Completion

August 19, 2022

Study Completion

August 19, 2022

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)