NCT02078947

Brief Summary

Aim of the clinical multicenter study (OptimEx-CLIN) is to assess the optimal exercise intervention in patients with Heart Failure with preserved Ejection Fraction (HFpEF; also termed diastolic heart failure) that will best improve peak oxygen uptake (Peak Vo2) and additionally diastolic function (assessed echocardiographically). The investigators hypothesize that exercise training reverses HFpEF and that intensity of exercise training is more important than duration.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

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

February 25, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 28, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2018

Completed
Last Updated

November 12, 2021

Status Verified

July 1, 2019

Enrollment Period

3.2 years

First QC Date

February 25, 2014

Last Update Submit

November 5, 2021

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Diastolic heart failure, Heart failure with preserved ejection fraction, exercise

Outcome Measures

Primary Outcomes (1)

  • Change in Peak VO2 after three months

    Change in Peak VO2 after three month intervention

    Baseline and three months

Secondary Outcomes (17)

  • Change in E/e' (representing diastolic filling pressure) at baseline and three months

    three months

  • Change in E/e' at baseline and 12 months

    12 months

  • Change in Peak VO2 at baseline and 12 months

    12 months

  • Change in NTproBNP at baseline and three months

    three months

  • Change in NTproBNP at baseline and 12 months

    12 months

  • +12 more secondary outcomes

Study Arms (3)

High Intensity Exercise

EXPERIMENTAL

Patients perform interval- type endurance exercise at high intensity

Behavioral: High Intensity Exercise

Moderate Continuous Exercise

ACTIVE COMPARATOR

Patients perform endurance exercise at moderate intensity

Behavioral: Moderate Continuous Exercise

Usual Care

SHAM COMPARATOR

Patients receive advice on being physically active as well as usual care

Behavioral: Usual Care

Interventions

High Intensity ExerciseBEHAVIORAL
High Intensity Exercise
Moderate Continuous ExerciseBEHAVIORAL
Moderate Continuous Exercise
Usual CareBEHAVIORAL
Usual Care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary (structured exercise \< 2x 30 min/wk)
  • At least 40 years old
  • Preserved systolic function LVEF \> 50%
  • Signs and symptoms of heart failure class NYHA II or III
  • Diastolic dysfunction (E/é \> 15 or E/é 8-15 and NT-proBNP \> 220 pg/ml)
  • Clinically stable for \>= 6 weeks
  • Optimal medical treatment for \>= 6 weeks
  • Written informed consent

You may not qualify if:

  • Non- HFpEF causes for HF symptoms (significant valvular or coronary disease, uncontrolled hypertension or arrhythmias, primary cardiomyopathies)
  • Significant pulmonary disease (FEV1 \< 50% predicted, COPD GOLD III-IV)
  • Inability to exercise or conditions that may interfere with exercise intervention
  • Myocardial infarction in the previous three months
  • Signs of ischemia during exercise testing
  • Comorbidity that may influence one- year prognosis
  • Participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Cardiology, Antwerp University Hospital

Edegem, 2650, Belgium

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik

Leipzig, 04289, Germany

Location

Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München

Munich, 80992, Germany

Location

Related Publications (7)

  • Gevaert AB, Witvrouwen I, Van Craenenbroeck AH, Van Laere SJ, Boen JRA, Van de Heyning CM, Belyavskiy E, Mueller S, Winzer E, Duvinage A, Edelmann F, Beckers PJ, Heidbuchel H, Wisloff U, Pieske B, Adams V, Halle M, Van Craenenbroeck EM; OptimEx-Clin Study Group. miR-181c level predicts response to exercise training in patients with heart failure and preserved ejection fraction: an analysis of the OptimEx-Clin trial. Eur J Prev Cardiol. 2021 Dec 29;28(15):1722-1733. doi: 10.1093/eurjpc/zwab151.

    PMID: 34508569RESULT

  • Mueller S, Haller B, Halle M; OptimEx-Clin Study Group. Effect of Training on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction-Reply. JAMA. 2021 Aug 24;326(8):772-773. doi: 10.1001/jama.2021.10061. No abstract available.

    PMID: 34427605RESULT

  • Gevaert AB, Bohm B, Hartmann H, Goovaerts I, Stoop T, Van De Heyning CM, Beckers PJ, Baldassarri F, Mueller S, Oberhoffer R, Duvinage A, Haykowsky MJ, Wisloff U, Adams V, Pieske B, Halle M, Van Craenenbroeck EM. Effect of Training on Vascular Function and Repair in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2023 Apr;11(4):454-464. doi: 10.1016/j.jchf.2022.12.011. Epub 2023 Mar 1.

    PMID: 36892488DERIVED

  • Winzer EB, Augstein A, Schauer A, Mueller S, Fischer-Schaepmann T, Goto K, Hommel J, van Craenenbroeck EM, Wisloff U, Pieske B, Halle M, Linke A, Adams V. Impact of Different Training Modalities on Molecular Alterations in Skeletal Muscle of Patients With Heart Failure With Preserved Ejection Fraction: A Substudy of the OptimEx Trial. Circ Heart Fail. 2022 Oct;15(10):e009124. doi: 10.1161/CIRCHEARTFAILURE.121.009124. Epub 2022 Oct 6.

    PMID: 36200450DERIVED

  • Gevaert AB, Mueller S, Winzer EB, Duvinage A, Van de Heyning CM, Pieske-Kraigher E, Beckers PJ, Edelmann F, Wisloff U, Pieske B, Adams V, Halle M, Van Craenenbroeck EM; OptimEx-Clin Study Group. Iron Deficiency Impacts Diastolic Function, Aerobic Exercise Capacity, and Patient Phenotyping in Heart Failure With Preserved Ejection Fraction: A Subanalysis of the OptimEx-Clin Study. Front Physiol. 2022 Feb 10;12:757268. doi: 10.3389/fphys.2021.757268. eCollection 2021.

    PMID: 35222057DERIVED

  • 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: 33560320DERIVED

  • 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: 25354950DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure, DiastolicMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martin Halle, M.D.

    Technische Universität München, Munich, Germany

    STUDY DIRECTOR

  • Martin Halle, M.D.

    Technische Universität München, Munich, Germany

    PRINCIPAL INVESTIGATOR

  • Burkert Pieske, M.D.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Christiaan Vrints, M.D.

    Antwerp University Hospital, Belgium

    PRINCIPAL INVESTIGATOR

  • Volker Adams, Ph.D.

    Heart Center Leipzig, Leipzig, Germany

    PRINCIPAL INVESTIGATOR

  • Ulrik Wisløff, Ph.D.

    Norwegian University of Science and Technology, Trondheim, Norway

    PRINCIPAL INVESTIGATOR

  • Axel Linke, M.D.

    Heart Center Leipzig, Leipzig, Germany

    PRINCIPAL INVESTIGATOR

  • Frank Edelmann, M.D.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 5, 2014

Study Start

July 28, 2014

Primary Completion

September 30, 2017

Study Completion

June 27, 2018

Last Updated

November 12, 2021

Record last verified: 2019-07

Locations

BE(1)DE(3)