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Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy? (WEDGE-HCM)

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ClinicalTrials.gov Identifier: NCT03537183
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Helga Gudmundsdottir, Bispebjerg Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Other: Exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy? - A Randomized Clinical Trial
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021


Arm Intervention/treatment
No Intervention: Usual activity level
12 weeks of usual activity level
Active Comparator: Exercise training
12 weeks of moderate intensity exercise training, 3 hours a week
Other: Exercise training
12 weeks, 3 hours a week, moderate intensity exercise training




Primary Outcome Measures :
  1. Change from baseline to follow-up in PCWP at 25 W [ Time Frame: 12 weeks ]
    Pulmonary capillary wedge pressure (mmHg)


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 years at the time of screening
  2. 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)
  3. Not exercising regularly (dedicated moderate or high-intensity exercise >1 hour weekly)
  4. NYHA class I-IV.

Exclusion Criteria:

  1. Phenocopies (i.e. syndromes, metabolic disorders (appendix 2))
  2. A history of exercise induced syncope within the last year, severe angina (CCS III-IV), hemodynamically severe valvular disorders
  3. Scheduled septal reduction therapy, less than 3 months after septal reduction therapy or known LVOT gradient above 30 mmHg at rest
  4. Severe hypertension (Systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg).
  5. Inability to exercise due to orthopedic or other non-cardiovascular limitations.
  6. Pregnancy
  7. Changes in medication that may affect exercise capacity and/or hemodynamics (i.e. beta blockers and calcium channel blockers)
  8. 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.

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): NCT03537183


Contacts
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Contact: Helga L Gudmundsdottir, MD 40632147 ext 0045 helgalilliang@gmail.com

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Helga L Gudmundsdottir    40632147    helga.lillian.gudmundsdottir@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Rigshospitalet, Denmark

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Responsible Party: Helga Gudmundsdottir, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03537183     History of Changes
Other Study ID Numbers: 63446
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helga Gudmundsdottir, Bispebjerg Hospital:
hypertrophic cardiomyopathy
exercise training
PCWP
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases