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

Primary Purpose

Hypertrophic Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate Intensity Exercise Program
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Left ventricular outflow tract gradient <30 mmHg at rest and with provocation. Left ventricular ejection fraction ≥ 50% by biplane Simpson's method. Access to exercise equipment at home or at a fitness center. Ability to complete study related testing including online surveys and smart phone use Ability to perform 24 weeks of exercise training Exclusion Criteria: History of exercise-induced syncope or ventricular arrhythmias LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after History of septal reduction therapy - surgery or ablation History of ICD placement in the previous 3 months 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) 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 Left ventricular ejection fraction less than 50% by echocardiography Life expectancy less than 12 months Pregnant or planned pregnancy Inability to exercise owing to any medical or other limitations 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.

Sites / Locations

  • University of California - San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Moderate Intensity Exercise arm

Usual physical activity arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in V O2 max
Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET
Change in peak VO2 %
Change in peak VO2 % predicted (%) by CPET

Secondary Outcome Measures

Change in Myocardial Systolic Strain
Change in Myocardial systolic strain (%) by echocardiography
Change in Myocardial Work
Change Myocardial work (mmHg%) by echocardiography

Full Information

First Posted
April 5, 2023
Last Updated
April 5, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05818605
Brief Title
Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy
Acronym
EXCITE-HCM
Official Title
The EXerCise traIning To rEcovery in HCM Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, blinded
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate Intensity Exercise arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual physical activity arm
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Moderate Intensity Exercise Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in V O2 max
Description
Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET
Time Frame
Baseline and 24 weeks
Title
Change in peak VO2 %
Description
Change in peak VO2 % predicted (%) by CPET
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Change in Myocardial Systolic Strain
Description
Change in Myocardial systolic strain (%) by echocardiography
Time Frame
Baseline and 24 Weeks
Title
Change in Myocardial Work
Description
Change Myocardial work (mmHg%) by echocardiography
Time Frame
Baseline and 24 weeks
Other Pre-specified Outcome Measures:
Title
Change in Myocardial Perfussion
Description
Change in Regional myocardial perfusion (ml/min/gm) by PET
Time Frame
Baseline and 24 Weeks
Title
Change in Coronary Flow reserve
Description
Change in coronary flow reserve (ratio, no unit) by PET
Time Frame
Baseline and 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Left ventricular outflow tract gradient <30 mmHg at rest and with provocation. Left ventricular ejection fraction ≥ 50% by biplane Simpson's method. Access to exercise equipment at home or at a fitness center. Ability to complete study related testing including online surveys and smart phone use Ability to perform 24 weeks of exercise training Exclusion Criteria: History of exercise-induced syncope or ventricular arrhythmias LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after History of septal reduction therapy - surgery or ablation History of ICD placement in the previous 3 months 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) 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 Left ventricular ejection fraction less than 50% by echocardiography Life expectancy less than 12 months Pregnant or planned pregnancy Inability to exercise owing to any medical or other limitations 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Partida-Higuera, CCRP
Phone
415-514-1125
Email
Cynthia.Partida-Higuera@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore P Abraham, M.D
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Partida-Higuera, CCRP
Phone
415-514-1125
Email
Cynthia.Partida-Higuera@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Theodore P Abraham, M.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

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