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

• Sponsor: Technische Universität München (Other)
• Overall Status: Completed
• CT.gov ID: NCT02078947
• Collaborator: European Commission (Other), University of Leipzig (Other), University Hospital, Antwerp (Other), Medical University of Graz (Other), Norwegian University of Science and Technology (Other), Charite University, Berlin, Germany (Other)
• Enrollment: 180
• Locations: 4
• Arms: 3
• Actual Duration (Months): 47
• Patients Per Site: 45
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction	Behavioral: High Intensity Exercise; Behavioral: Moderate Continuous Exercise; Behavioral: Usual Care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• 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
• Actual Study Start Date: Jul 28, 2014
• Actual Primary Completion Date: Sep 30, 2017
• Actual Study Completion Date: Jun 27, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Peak VO2 after three months [Baseline and three months]

   Change in Peak VO2 after three month intervention

Secondary Outcome Measures

1. Change in E/e' (representing diastolic filling pressure) at baseline and three months [three months]

   Change in E/e' (representing diastolic filling pressure) at baseline and three months

2. Change in E/e' at baseline and 12 months [12 months]

   Change in E/e' at baseline and 12 months

3. Change in Peak VO2 at baseline and 12 months [12 months]

   Change in Peak VO2 at baseline and 12 months

4. Change in NTproBNP at baseline and three months [three months]

   Change in NTproBNP at baseline and three months

5. Change in NTproBNP at baseline and 12 months [12 months]

   Change in NTproBNP at baseline and 12 months

6. Change in health related quality of life at baseline and three months [three months]

   Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and three months

7. Change in health related Quality of life at baseline and 12 months [12 months]

   Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and 12 months

8. Change in Left Atrial Volume Index (LAVI) at baseline and three months [three months]

   Change in Left Atrial Volume Index (LAVI) at baseline and three months

9. Change in Left Atrial Volume Index (LAVI) at baseline and 12 months [12 months]

   Change in Left Atrial Volume Index (LAVI) at baseline and 12 months

10. Change in e' medial at baseline and three months [three months]

    Change in e' medial at baseline and three months

11. Change in e' at baseline and 12 months [12 months]

    Change in e' at baseline and 12 months

12. Change in submaximal exercise capacity at baseline and three months [three months]

    submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)

13. Change in submaximal exercise capacity at baseline and 12 months [12 months]

    Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)

14. Change in VE/VCO2 slope at baseline and three months [three months]

    Change in VE/VCO2 slope at baseline and three months

15. Change in VE/VCO2 slope at baseline and 12 months [12 months]

    Change in VE/VCO2 slope at baseline and 12 months

16. Change in Flow Mediated Dilation (FMD) at baseline and three months [three months]

    Change in Flow Mediated Dilation (FMD) at baseline and three months

17. Change in Flow Mediated Dilation (FMD) at baseline and 12 months [12 months]

    Change in Flow Mediated Dilation (FMD) at baseline and 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, Antwerp University Hospital	Edegem		Belgium	2650
2	Charité - Universitätsmedizin Berlin	Berlin		Germany
3	Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik	Leipzig		Germany	04289
4	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Technische Universität München
• ClinicalTrials.gov Identifier: NCT02078947
• Other Study ID Numbers: EU 602405-2
• First Posted: Mar 5, 2014
• Last Update Posted: Nov 12, 2021
• Last Verified: Jul 1, 2019

• 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

Study Results

No Results Posted as of Nov 12, 2021