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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02078947
First Posted: March 5, 2014
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
European Commission
University of Leipzig
University Hospital, Antwerp
Medical University of Graz
Norwegian University of Science and Technology
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Technische Universität München
  Purpose
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.

Condition Intervention
Heart Failure With Preserved Ejection Fraction Behavioral: High Intensity Exercise Behavioral: Moderate Continuous Exercise Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure- Clinical Study

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Change in Peak VO2 after three months [ Time Frame: Baseline and three months ]
    Change in Peak VO2 after three month intervention


Secondary Outcome Measures:
  • 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

  • Change in E/e' at baseline and 12 months [ Time Frame: 12 months ]
    Change in E/e' at baseline and 12 months

  • Change in Peak VO2 at baseline and 12 months [ Time Frame: 12 months ]
    Change in Peak VO2 at baseline and 12 months

  • Change in NTproBNP at baseline and three months [ Time Frame: three months ]
    Change in NTproBNP at baseline and three months

  • Change in NTproBNP at baseline and 12 months [ Time Frame: 12 months ]
    Change in NTproBNP at baseline and 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

  • 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

  • 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

  • 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

  • Change in e' medial at baseline and three months [ Time Frame: three months ]
    Change in e' medial at baseline and three months

  • Change in e' at baseline and 12 months [ Time Frame: 12 months ]
    Change in e' at baseline and 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)

  • 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)

  • Change in VE/VCO2 slope at baseline and three months [ Time Frame: three months ]
    Change in VE/VCO2 slope at baseline and 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

  • 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

  • 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


Enrollment: 180
Study Start Date: June 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078947


Locations
Belgium
Department of Cardiology, Antwerp University Hospital
Edegem, Belgium, 2650
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik
Leipzig, Germany, 04289
Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München
Munich, Germany, 80992
Sponsors and Collaborators
Technische Universität München
European Commission
University of Leipzig
University Hospital, Antwerp
Medical University of Graz
Norwegian University of Science and Technology
Charite University, Berlin, Germany
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02078947     History of Changes
Other Study ID Numbers: EU 602405-2
First Submitted: February 25, 2014
First Posted: March 5, 2014
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Technische Universität München:
Diastolic heart failure, Heart failure with preserved ejection fraction, exercise

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases