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

NCT03537183 | Completed DMC

• 1 other identifier: 63446
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

hypertrophic cardiomyopathy; exercise training; PCWP

Outcome Measures

Primary Outcomes (1)

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

  Pulmonary capillary wedge pressure (mmHg)

  12 weeks

Secondary Outcomes (13)

• Pulmonary capillary wedge pressure

  12 weeks

• Workload adjusted Pulmonary capillary wedge pressure

  12 weeks

• Systemic vascular resistance

  12 weeks

• Exercise capacity

  12 weeks

• Heart rate

  12 weeks

Other Outcomes (1)

• Left ventricular fibrosis

  12 weeks

Study Arms (2)

Usual activity level

NO INTERVENTION

12 weeks of usual activity level

Exercise training

ACTIVE COMPARATOR

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

Other: Exercise training

Interventions

Exercise training OTHER

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

Exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Gudmundsdottir HL, Axelsson Raja A, Rossing K, Rasmusen H, Snoer M, Andersen LJ, Gottlieb R, Christensen AH, Bundgaard H, Gustafsson F, Thune JJ. Exercise Training in Patients With Hypertrophic Cardiomyopathy Without Left Ventricular Outflow Tract Obstruction: A Randomized Clinical Trial. Circulation. 2025 Jan 14;151(2):132-144. doi: 10.1161/CIRCULATIONAHA.124.070064. Epub 2024 Nov 8.

  PMID: 39513255 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 25, 2018
• Study Start: September 1, 2018
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

DK (1)