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

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
High Intensity Exercise
Moderate Continuous Exercise
Usual Care
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring Diastolic heart failure, Heart failure with preserved ejection fraction, exercise

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

High Intensity Exercise

Moderate Continuous Exercise

Usual Care

Arm Description

Patients perform interval- type endurance exercise at high intensity

Patients perform endurance exercise at moderate intensity

Patients receive advice on being physically active as well as usual care

Outcomes

Primary Outcome Measures

Change in Peak VO2 after 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
Change in E/e' (representing diastolic filling pressure) at baseline and three months
Change in E/e' at baseline and 12 months
Change in E/e' at baseline and 12 months
Change in Peak VO2 at baseline and 12 months
Change in Peak VO2 at baseline and 12 months
Change in NTproBNP at baseline and three months
Change in NTproBNP at baseline and three months
Change in NTproBNP at baseline and 12 months
Change in NTproBNP at baseline and 12 months
Change in health related quality of life at baseline and 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
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
Change in Left Atrial Volume Index (LAVI) at baseline and three months
Change in Left Atrial Volume Index (LAVI) at baseline and 12 months
Change in Left Atrial Volume Index (LAVI) at baseline and 12 months
Change in e' medial at baseline and three months
Change in e' medial at baseline and three months
Change in e' at baseline and 12 months
Change in e' at baseline and 12 months
Change in submaximal exercise capacity at baseline and 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
Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)
Change in VE/VCO2 slope at baseline and three months
Change in VE/VCO2 slope at baseline and three months
Change in VE/VCO2 slope at baseline and 12 months
Change in VE/VCO2 slope at baseline and 12 months
Change in Flow Mediated Dilation (FMD) at baseline and three months
Change in Flow Mediated Dilation (FMD) at baseline and three months
Change in Flow Mediated Dilation (FMD) at baseline and 12 months
Change in Flow Mediated Dilation (FMD) at baseline and 12 months

Full Information

First Posted
February 25, 2014
Last Updated
November 5, 2021
Sponsor
Technical University of Munich
Collaborators
European Commission, University of Leipzig, University Hospital, Antwerp, Medical University of Graz, Norwegian University of Science and Technology, Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02078947
Brief Title
Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure
Acronym
OptimEx-Clin
Official Title
Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure- Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 28, 2014 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
June 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
European Commission, University of Leipzig, University Hospital, Antwerp, Medical University of Graz, Norwegian University of Science and Technology, Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
Diastolic heart failure, Heart failure with preserved ejection fraction, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Exercise
Arm Type
Experimental
Arm Description
Patients perform interval- type endurance exercise at high intensity
Arm Title
Moderate Continuous Exercise
Arm Type
Active Comparator
Arm Description
Patients perform endurance exercise at moderate intensity
Arm Title
Usual Care
Arm Type
Sham Comparator
Arm Description
Patients receive advice on being physically active as well as usual care
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Exercise
Intervention Type
Behavioral
Intervention Name(s)
Moderate Continuous Exercise
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Change in Peak VO2 after three months
Description
Change in Peak VO2 after three month intervention
Time Frame
Baseline and three months
Secondary Outcome Measure Information:
Title
Change in E/e' (representing diastolic filling pressure) at baseline and three months
Description
Change in E/e' (representing diastolic filling pressure) at baseline and three months
Time Frame
three months
Title
Change in E/e' at baseline and 12 months
Description
Change in E/e' at baseline and 12 months
Time Frame
12 months
Title
Change in Peak VO2 at baseline and 12 months
Description
Change in Peak VO2 at baseline and 12 months
Time Frame
12 months
Title
Change in NTproBNP at baseline and three months
Description
Change in NTproBNP at baseline and three months
Time Frame
three months
Title
Change in NTproBNP at baseline and 12 months
Description
Change in NTproBNP at baseline and 12 months
Time Frame
12 months
Title
Change in health related quality of life at baseline and three months
Description
Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and three months
Time Frame
three months
Title
Change in health related Quality of life at baseline and 12 months
Description
Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and 12 months
Time Frame
12 months
Title
Change in Left Atrial Volume Index (LAVI) at baseline and three months
Description
Change in Left Atrial Volume Index (LAVI) at baseline and three months
Time Frame
three months
Title
Change in Left Atrial Volume Index (LAVI) at baseline and 12 months
Description
Change in Left Atrial Volume Index (LAVI) at baseline and 12 months
Time Frame
12 months
Title
Change in e' medial at baseline and three months
Description
Change in e' medial at baseline and three months
Time Frame
three months
Title
Change in e' at baseline and 12 months
Description
Change in e' at baseline and 12 months
Time Frame
12 months
Title
Change in submaximal exercise capacity at baseline and three months
Description
submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)
Time Frame
three months
Title
Change in submaximal exercise capacity at baseline and 12 months
Description
Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)
Time Frame
12 months
Title
Change in VE/VCO2 slope at baseline and three months
Description
Change in VE/VCO2 slope at baseline and three months
Time Frame
three months
Title
Change in VE/VCO2 slope at baseline and 12 months
Description
Change in VE/VCO2 slope at baseline and 12 months
Time Frame
12 months
Title
Change in Flow Mediated Dilation (FMD) at baseline and three months
Description
Change in Flow Mediated Dilation (FMD) at baseline and three months
Time Frame
three months
Title
Change in Flow Mediated Dilation (FMD) at baseline and 12 months
Description
Change in Flow Mediated Dilation (FMD) at baseline and 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Halle, M.D.
Organizational Affiliation
Technische Universität München, Munich, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Halle, M.D.
Organizational Affiliation
Technische Universität München, Munich, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burkert Pieske, M.D.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christiaan Vrints, M.D.
Organizational Affiliation
Antwerp University Hospital, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Volker Adams, Ph.D.
Organizational Affiliation
Heart Center Leipzig, Leipzig, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrik Wisløff, Ph.D.
Organizational Affiliation
Norwegian University of Science and Technology, Trondheim, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Axel Linke, M.D.
Organizational Affiliation
Heart Center Leipzig, Leipzig, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Edelmann, M.D.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München
City
Munich
ZIP/Postal Code
80992
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34508569
Citation
Gevaert AB, Witvrouwen I, Van Craenenbroeck AH, Van Laere SJ, Boen JRA, Van de Heyning CM, Belyavskiy E, Mueller S, Winzer E, Duvinage A, Edelmann F, Beckers PJ, Heidbuchel H, Wisloff U, Pieske B, Adams V, Halle M, Van Craenenbroeck EM; OptimEx-Clin Study Group. miR-181c level predicts response to exercise training in patients with heart failure and preserved ejection fraction: an analysis of the OptimEx-Clin trial. Eur J Prev Cardiol. 2021 Dec 29;28(15):1722-1733. doi: 10.1093/eurjpc/zwab151.
Results Reference
result
PubMed Identifier
34427605
Citation
Mueller S, Haller B, Halle M; OptimEx-Clin Study Group. Effect of Training on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction-Reply. JAMA. 2021 Aug 24;326(8):772-773. doi: 10.1001/jama.2021.10061. No abstract available.
Results Reference
result
PubMed Identifier
36200450
Citation
Winzer EB, Augstein A, Schauer A, Mueller S, Fischer-Schaepmann T, Goto K, Hommel J, van Craenenbroeck EM, Wisloff U, Pieske B, Halle M, Linke A, Adams V. Impact of Different Training Modalities on Molecular Alterations in Skeletal Muscle of Patients With Heart Failure With Preserved Ejection Fraction: A Substudy of the OptimEx Trial. Circ Heart Fail. 2022 Oct;15(10):e009124. doi: 10.1161/CIRCHEARTFAILURE.121.009124. Epub 2022 Oct 6.
Results Reference
derived
PubMed Identifier
35222057
Citation
Gevaert AB, Mueller S, Winzer EB, Duvinage A, Van de Heyning CM, Pieske-Kraigher E, Beckers PJ, Edelmann F, Wisloff U, Pieske B, Adams V, Halle M, Van Craenenbroeck EM; OptimEx-Clin Study Group. Iron Deficiency Impacts Diastolic Function, Aerobic Exercise Capacity, and Patient Phenotyping in Heart Failure With Preserved Ejection Fraction: A Subanalysis of the OptimEx-Clin Study. Front Physiol. 2022 Feb 10;12:757268. doi: 10.3389/fphys.2021.757268. eCollection 2021.
Results Reference
derived
PubMed Identifier
33560320
Citation
Mueller S, Winzer EB, Duvinage A, Gevaert AB, Edelmann F, Haller B, Pieske-Kraigher E, Beckers P, Bobenko A, Hommel J, Van de Heyning CM, Esefeld K, von Korn P, Christle JW, Haykowsky MJ, Linke A, Wisloff U, Adams V, Pieske B, van Craenenbroeck EM, Halle M; OptimEx-Clin Study Group. Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2021 Feb 9;325(6):542-551. doi: 10.1001/jama.2020.26812.
Results Reference
derived
PubMed Identifier
25354950
Citation
Suchy C, Massen L, Rognmo O, Van Craenenbroeck EM, Beckers P, Kraigher-Krainer E, Linke A, Adams V, Wisloff U, Pieske B, Halle M. Optimising exercise training in prevention and treatment of diastolic heart failure (OptimEx-CLIN): rationale and design of a prospective, randomised, controlled trial. Eur J Prev Cardiol. 2014 Nov;21(2 Suppl):18-25. doi: 10.1177/2047487314552764.
Results Reference
derived
Links:
URL
http://www.ntnu.edu/optimex
Description
Related Info

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Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure

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