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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Technische Universität München
Sponsor:
Collaborators:
European Commission
University of Leipzig
University Hospital, Antwerp
Medical University of Graz
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT02078947
First received: February 25, 2014
Last updated: June 30, 2014
Last verified: June 2014
  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 Phase
Heart Failure With Preserved Ejection Fraction
Behavioral: High Intensity Exercise
Behavioral: Moderate Continuous Exercise
Behavioral: Usual Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in E/e' at baseline and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Peak VO2 at baseline and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in NTproBNP at baseline and three months [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Change in NTproBNP at baseline and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in health related quality of life at baseline and three months [ Time Frame: three months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Left Atrial Volume Index (LAVI) at baseline and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in e' medial at baseline and three months [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Change in e' at baseline and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in submaximal exercise capacity at baseline and three months [ Time Frame: three months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in VE/VCO2 slope at baseline and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Flow Mediated Dilation (FMD) at baseline and three months [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Change in Flow Mediated Dialation (FMD) at baseline and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: June 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078947

Contacts
Contact: Christiane Heinrich, M.D. +498928924446 heinrich@sport.med.tum.de

Locations
Austria
University Heart Center, Medical University Graz Not yet recruiting
Graz, Austria, 8036
Belgium
Department of Cardiology, Antwerp University Hospital Not yet recruiting
Edegem, Belgium, 2650
Germany
Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik Not yet recruiting
Leipzig, Germany, 04289
Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München Recruiting
Munich, Germany, 80992
Norway
Department of Circulation and Medical Imaging, Norwegian University of Science and Technology Not yet recruiting
Trondheim, Norway, 7491
Sponsors and Collaborators
Technische Universität München
European Commission
University of Leipzig
University Hospital, Antwerp
Medical University of Graz
Norwegian University of Science and Technology
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. Medical University Graz, Austria
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
  More Information

Additional Information:
No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02078947     History of Changes
Other Study ID Numbers: EU 602405-2
Study First Received: February 25, 2014
Last Updated: June 30, 2014
Health Authority: Germany: Ethics Commisson

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

ClinicalTrials.gov processed this record on July 24, 2014