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NCT Number: NCT03537183

Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy?

Aims and objectives: The primary objective of this study is to assess whether a structured exercise program improves cardiac relaxing properties in patients with hypertrophic cardiomyopathy (HCM).

Background: HCM is a hereditary disease in which the myocardium becomes thickened without an identifiable cause (other than genetic). It is the most common genetic cardiovascular disease with an estimated prevalence of 1/500 (i.e. 10.000 affected individuals in Denmark). The majority of patients with HCM suffers from shortness of breath and reduced exercise capacity due to increased left ventricular (LV) stiffness. Exercise training has been shown to improve exercise capacity and symptoms in patients with HCM, but the mechanisms responsible for this improvement are not known.

Methods and materials: The study is a randomized, single blinded, prospective, controlled clinical trial. Eighty patients are recruited from outpatient clinics in the Capital Region of Denmark. Patients are randomized in a 1:1 ratio to 12 week of moderate-intensity exercise training or usual activity level. Assessments will include right heart catheterization, echocardiography, cardiopulmonary exercise testing, blood-samples, quality of life, and, in a subgroup of patients, cardiac magnetic resonance imaging. The primary end-point is change in LV filling pressure assessed as pulmonary capillary wedge pressure at 25 W workload.

Expected outcome and perspectives: The investigators hypothesize that an exercise training program will reduce cardiac stiffness and improve symptoms in patients with HCM. Training of HCM patients has long been debated and the topic is poorly researched. The effects of exercise on hemodynamics in HCM patients are unknown and a better understanding of these mechanisms is pivotal for improving treatment.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years at the time of screening
  • Documented phenotypic HCM (maximal wall thickness ≥15mm, or ≥13mm in a first degree relative with a definite or likely disease causing genetic mutation (appendix 1)
  • Not exercising regularly (dedicated moderate or high-intensity exercise >1 hour weekly)
  • NYHA class I-IV.

Exclusion criteria

  • Phenocopies (i.e. syndromes, metabolic disorders (appendix 2))
  • A history of exercise induced syncope within the last year, severe angina (CCS III-IV), hemodynamically severe valvular disorders
  • Scheduled septal reduction therapy, less than 3 months after septal reduction therapy or known LVOT gradient above 30 mmHg at rest
  • Severe hypertension (Systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg).
  • Inability to exercise due to orthopedic or other non-cardiovascular limitations.
  • Pregnancy
  • Changes in medication that may affect exercise capacity and/or hemodynamics (i.e. beta blockers and calcium channel blockers)
  • Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.

Treatment and study plan

Exercise training

Other

12 weeks, 3 hours a week, moderate intensity exercise training

Primary outcomes

  1. Change from baseline to follow-up in PCWP at 25 W

    Time frame: 12 weeks

    Pulmonary capillary wedge pressure (mmHg)

Secondary outcomes

  1. Pulmonary capillary wedge pressure

    Time frame: 12 weeks

    At rest, at 25% and 50% of the maximum workload and at maximum workload ( measured as mmHg)

  2. Workload adjusted Pulmonary capillary wedge pressure

    Time frame: 12 weeks

    At rest, at 25% and 50% of the maximum workload and at maximum workload, measured as mmHg/kg/W

  3. Systemic vascular resistance

    Time frame: 12 weeks

    Resting and exercise systemic vascular resistance at rest, 25 W, 25% and 50% of the maximum workload and at maximum workload ( measured as mmHg)

  4. Exercise capacity

    Time frame: 12 weeks

    Measured as watt at maximum workload

  5. Heart rate

    Time frame: 12 weeks

    At rest, during exercise and at maximum exercise capacity (beats/min)

  6. Blood pressure

    Time frame: 12 weeks

    At rest, at maximum workload, 6 minutes after cease of workload (mmHg)

  7. Cardiac index

    Time frame: 12 weeks

    At rest, 25W and at maximum workload (L/min/m2):

  8. Arterio-venous difference

    Time frame: 12 weeks

    At rest, 25W and at maximum workload (ml O2/L)and workload corrected (mlO2/L/W)

  9. VO2 max

    Time frame: 12 weeks

    Measered as ml O2/min/kg

  10. Quality of life questionnaire

    Time frame: 12 weeks

    Measured by Kansas City Cardiomyopathy score

  11. NT-Pro-BNP

    Time frame: 12 weeks

    (pmol/L)

  12. Troponin-T

    Time frame: 12 weeks

    (mmol/L)

  13. Echocardiographic parameters

    Time frame: 12 weeks

    At rest: E/e'-ratio, E/A-ratio, deceleration time, LVOT gradient (mmHg). During exercise from 25W to maximum workload: E/e'-ratio, E/A-ratio, deceleration time, LVOT gradient(mmHg).

Other outcomes

  1. Left ventricular fibrosis

    Time frame: 12 weeks

    (assessed as late gadolinum enhancement) and extracellular volume (assessed using T1-mapping) will be assessed in the subgroup of patients without contraindications to CMR and will be correlated to LV filling pressures.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy? - A Randomized Clinical Trial

Acronym: WEDGE-HCM

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 25, 2018
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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