Skip to main content
OpenTrials
Completed

NCT Number: NCT02078947

Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure With Preserved Ejection Fraction Behavior Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Diastolic Motor Activity

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Antwerp University Hospital, Edegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

High intensity exercise

Behavioral

Moderate Continuous Exercise

Behavioral

Usual Care

Behavioral

Primary outcomes

  1. Change in Peak VO2 after three months

    Time frame: Baseline and three months

    Change in Peak VO2 after three month intervention

Secondary outcomes

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

    Time frame: three months

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

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

    Time frame: 12 months

    Change in E/e' at baseline and 12 months

  3. Change in Peak VO2 at baseline and 12 months

    Time frame: 12 months

    Change in Peak VO2 at baseline and 12 months

  4. Change in NTproBNP at baseline and three months

    Time frame: three months

    Change in NTproBNP at baseline and three months

  5. Change in NTproBNP at baseline and 12 months

    Time frame: 12 months

    Change in NTproBNP at baseline and 12 months

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

    Time frame: three months

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

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

    Time frame: 12 months

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

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

    Time frame: three months

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

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

    Time frame: 12 months

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

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

    Time frame: three months

    Change in e' medial at baseline and three months

  11. Change in e' at baseline and 12 months

    Time frame: 12 months

    Change in e' at baseline and 12 months

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

    Time frame: three months

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

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

    Time frame: 12 months

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

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

    Time frame: three months

    Change in VE/VCO2 slope at baseline and three months

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

    Time frame: 12 months

    Change in VE/VCO2 slope at baseline and 12 months

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

    Time frame: three months

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

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

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Charite University, Berlin, Germany
  • European Commission
  • Medical University of Graz
  • Norwegian University of Science and Technology
  • University Hospital, Antwerp
  • University of Leipzig

Registry information

Official study title

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

Acronym: OptimEx-Clin

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Mar 5, 2014
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.