Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy (EXCITE-HCM)

The EXerCise traIning To rEcovery in HCM Trial

The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention.

Study Overview

• Status: Recruiting
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Behavioral: Moderate Intensity Exercise Program

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Partida-Higuera, CCRP; Phone Number: 415-514-1125; Email: Cynthia.Partida-Higuera@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California - San Francisco
      • Contact: Cynthia Partida-Higuera, CCRP; Phone Number: 415-514-1125; Email: Cynthia.Partida-Higuera@ucsf.edu
      • Principal Investigator: Theodore P Abraham, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
2. Left ventricular outflow tract gradient <30 mmHg at rest and with provocation.
3. Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
4. Access to exercise equipment at home or at a fitness center.
5. Ability to complete study related testing including online surveys and smart phone use
6. Ability to perform 24 weeks of exercise training

Exclusion Criteria:

1. History of exercise-induced syncope or ventricular arrhythmias
2. LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
3. History of septal reduction therapy - surgery or ablation
4. History of ICD placement in the previous 3 months
5. History of hypotensive response with exercise testing (>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure >20 mm Hg)
6. Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian Cardiovascular Society class IV angina symptoms
7. Left ventricular ejection fraction less than 50% by echocardiography
8. Life expectancy less than 12 months
9. Pregnant or planned pregnancy
10. Inability to exercise owing to any medical or other limitations
11. Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Intensity Exercise arm; All patients randomized to the exercise training group will undergo a single supervised in-hospital exercise session that includes an exercise consultation with a certified exercise physiologist. Following that they will exercise at-home with video supervision 3 times a week for a period of 24 weeks.	Behavioral: Moderate Intensity Exercise Program; Subjects randomized to the EXER arm will undergo 24 weeks of Moderate Intensity Exercise Training (MIET). Patients will be signed up for 60-minute exercise sessions, 3 times a week
No Intervention: Usual physical activity arm; Patients randomized to the usual-activity group will be instructed to continue their current activity without initiating or intensifying any existing exercise regimens for the duration of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in V O2 max	Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET	Baseline and 24 weeks
Change in peak VO2 %	Change in peak VO2 % predicted (%) by CPET	Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Myocardial Systolic Strain	Change in Myocardial systolic strain (%) by echocardiography	Baseline and 24 Weeks
Change in Myocardial Work	Change Myocardial work (mmHg%) by echocardiography	Baseline and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Myocardial Perfussion	Change in Regional myocardial perfusion (ml/min/gm) by PET	Baseline and 24 Weeks
Change in Coronary Flow reserve	Change in coronary flow reserve (ratio, no unit) by PET	Baseline and 24 Weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Theodore P Abraham, M.D, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Anticipated): March 1, 2027
• Study Completion (Anticipated): March 1, 2027

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: R01HL157238 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No