Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure (OptimEx-Clin)

November 5, 2021 updated by: Technical University of Munich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Department of Cardiology, Antwerp University Hospital
  • Germany
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin
      • Leipzig, Germany, 04289
        • Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik
      • Munich, Germany, 80992
        • Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity Exercise
Patients perform interval- type endurance exercise at high intensity
Behavioral: High Intensity Exercise
Active Comparator: Moderate Continuous Exercise
Patients perform endurance exercise at moderate intensity
Behavioral: Moderate Continuous Exercise
Sham Comparator: Usual Care
Patients receive advice on being physically active as well as usual care
Behavioral: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peak VO2 after three months
Time Frame: Baseline and three months
Change in Peak VO2 after three month intervention
Baseline and three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three months
Change in E/e' at baseline and 12 months
Time Frame: 12 months
Change in E/e' at baseline and 12 months
12 months
Change in Peak VO2 at baseline and 12 months
Time Frame: 12 months
Change in Peak VO2 at baseline and 12 months
12 months
Change in NTproBNP at baseline and three months
Time Frame: three months
Change in NTproBNP at baseline and three months
three months
Change in NTproBNP at baseline and 12 months
Time Frame: 12 months
Change in NTproBNP at baseline and 12 months
12 months
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
three months
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
12 months
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
three months
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
12 months
Change in e' medial at baseline and three months
Time Frame: three months
Change in e' medial at baseline and three months
three months
Change in e' at baseline and 12 months
Time Frame: 12 months
Change in e' at baseline and 12 months
12 months
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)
three months
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)
12 months
Change in VE/VCO2 slope at baseline and three months
Time Frame: three months
Change in VE/VCO2 slope at baseline and three months
three months
Change in VE/VCO2 slope at baseline and 12 months
Time Frame: 12 months
Change in VE/VCO2 slope at baseline and 12 months
12 months
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
three months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

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

Investigators

  • Study Director: Martin Halle, M.D., Technische Universität München, Munich, Germany
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2014

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

June 27, 2018

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU 602405-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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