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Heart Failure With Preserved Ejection FractionOptimEx-ClinNCT02078947

Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure

A study testing High Intensity Exercise and Moderate Continuous Exercise in people with Heart Failure With Preserved Ejection Fraction, run by Technical University of Munich at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
High Intensity Exercise and Moderate Continuous Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
4 sitesin 2 countries
Study dates
28 Jul 2014to 27 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Germany3 sites

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik

    Leipzig, 04289

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

    Munich, 80992

Other trials in Germany

Belgium1 site

  • Department of Cardiology, Antwerp University Hospital

    Edegem, 2650

Other trials in Belgium

About this study

Official title: Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure- Clinical Study

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.

Being tested
High Intensity Exercise, Moderate Continuous Exercise, Usual Care
Keywords
Diastolic heart failure, Heart failure with preserved ejection fraction, exercise
Medical subject headings
Heart Failure, Diastolic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity ExerciseBehavioural

  • Moderate Continuous ExerciseBehavioural

  • Usual CareBehavioural

Study groups in NCT02078947
Study groupRoleWhat they receive
High Intensity ExerciseExperimentalPatients perform interval- type endurance exercise at high intensity
Receives: Behavioral: High Intensity Exercise
Moderate Continuous ExerciseActive comparatorPatients perform endurance exercise at moderate intensity
Receives: Behavioral: Moderate Continuous Exercise
Usual CareSham comparatorPatients receive advice on being physically active as well as usual care
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Peak VO2 after three months

    Change in Peak VO2 after three month intervention

    Measured: Baseline and three months

Secondary outcomes (17)

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

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

    Measured: three months

  2. Change in E/e' at baseline and 12 months

    Change in E/e' at baseline and 12 months

    Measured: 12 months

  3. Change in Peak VO2 at baseline and 12 months

    Change in Peak VO2 at baseline and 12 months

    Measured: 12 months

  4. Change in NTproBNP at baseline and three months

    Change in NTproBNP at baseline and three months

    Measured: three months

  5. Change in NTproBNP at baseline and 12 months

    Change in NTproBNP at baseline and 12 months

    Measured: 12 months

  6. Change in health related quality of life at baseline and three months

    Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and three months

    Measured: three months

  7. Change in health related Quality of life at baseline and 12 months

    Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and 12 months

    Measured: 12 months

  8. Change in Left Atrial Volume Index (LAVI) at baseline and three months

    Change in Left Atrial Volume Index (LAVI) at baseline and three months

    Measured: three months

  9. Change in Left Atrial Volume Index (LAVI) at baseline and 12 months

    Change in Left Atrial Volume Index (LAVI) at baseline and 12 months

    Measured: 12 months

  10. Change in e' medial at baseline and three months

    Change in e' medial at baseline and three months

    Measured: three months

  11. Change in e' at baseline and 12 months

    Change in e' at baseline and 12 months

    Measured: 12 months

  12. Change in submaximal exercise capacity at baseline and three months

    submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)

    Measured: three months

  13. Change in submaximal exercise capacity at baseline and 12 months

    Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)

    Measured: 12 months

  14. Change in VE/VCO2 slope at baseline and three months

    Change in VE/VCO2 slope at baseline and three months

    Measured: three months

  15. Change in VE/VCO2 slope at baseline and 12 months

    Change in VE/VCO2 slope at baseline and 12 months

    Measured: 12 months

  16. Change in Flow Mediated Dilation (FMD) at baseline and three months

    Change in Flow Mediated Dilation (FMD) at baseline and three months

    Measured: three months

  17. Change in Flow Mediated Dilation (FMD) at baseline and 12 months

    Change in Flow Mediated Dilation (FMD) at baseline and 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2014 (estimated)
  2. Study start28 Jul 2014
  3. Primary completion30 Sep 2017
  4. Study completion27 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02078947
Sponsor's protocol ID
EU 602405-2
Acronym
OptimEx-Clin
Status last verified
Jul 2019
First submitted
25 Feb 2014
Last updated
12 Nov 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34508569

  • 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.

    PubMed 34427605

  • Fegers-Wustrow I, Haykowsky MJ, Winzer EB, Adams V, Wisloff U, Gevaert AB, van Craenenbroeck EM, Wachter R, Pieske B, Edelmann F, Halle M, Mueller-Stegner S. Sex Differences in Exercise Training Response Among HFpEF Patients: Pooled Analysis of OptimEx-Clin and Ex-DHF-Trials. Eur J Heart Fail. 2026 Jul 29:xuag240. doi: 10.1093/ejhf/xuag240. Online ahead of print.

    PubMed 42522564

  • Dinges SM, Schwedhelm E, Baldassarri F, Haller B, Gevaert AB, Boger R, Winzer EB, Edelmann F, Wisloff U, Adams V, Pieske B, Van Craenenbroeck EM, Halle M, Hofmann SM, Mueller-Stegner S. Circulating nitric oxide pathway metabolites in heart failure with preserved ejection fraction: a sex-stratified cross-sectional analysis. Biol Sex Differ. 2026 Jun 15;17(1):120. doi: 10.1186/s13293-026-00940-7.

    PubMed 42298662

  • 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.

    PubMed 36892488

  • 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.

    PubMed 36200450

  • 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.

    PubMed 35222057

  • 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.

    PubMed 33560320

  • 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.

    PubMed 25354950

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Exercise and Moderate Continuous Exercise in people with Heart Failure With Preserved Ejection Fraction, run by Technical University of Munich at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Peak VO2 after three months (time frame: Baseline and three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078947, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.

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