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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Munich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Graz
Charite University, Berlin, Germany
Norwegian University of Science and Technology
University of Leipzig
University Hospital, Antwerp
European Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings