- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01127061
Study of Exercise Training in Hypertrophic Cardiomyopathy (RESET-HCM)
A Randomized Trial of Moderate Intensity Exercise Training in Hypertrophic Cardiomyopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Cardiovascular Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years and ≤ 80.
- Diagnosis of HCM, defined by the presence of unexplained left-ventricular hypertrophy > 13 mm in any wall segment.
- Agreement to be a participant in the study protocol and willing/able to return for follow-up.
Exclusion Criteria:
- History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
- Medically refractory left ventricular outflow tract obstruction being evaluated for septal reduction therapy.
- Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
- Hypotensive response to exercise (> 20 mm Hg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
- Pregnancy.
- Implantable Cardioverter-Defibrillator (ICD) placement in last 3 months or scheduled.
- Left ventricular systolic dysfunction (left ventricular ejection fraction < 55% by echocardiography).
- Worsening clinical status in the last 3 months, advanced heart failure (New York Heart Association class IV symptoms) or angina (Canadian Cardiovascular Society class IV symptoms).
- Life expectancy less than 12 months.
- Inability to exercise due to orthopedic or other non-cardiovascular limitations.
- Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Exercise Training
Participants in the exercise group will undergo 4 months of training, 4-7 days per week with a minimum of 20 minutes per day.
The protocol will be custom designed in consultation with an exercise physiologist based on data from the initial cardiopulmonary stress test.
Exercise regimen will begin at a low level of intensity then increase in duration and training intensity to a goal of 60 minutes a day and 70% of the heart rate reserve during the 1st month of the study protocol with maintenance of the program thereafter.
There is no need to come to a participating site for actually doing the exercise regimen.
No strength training or burst activity will be prescribed and all activities will fall well within the recommended national guidelines for recreational exercise.
|
4 months of exercise training that is custom-designed based on individual cardiopulmonary stress test data.
Regimen starts at low intensity (60% of heart rate reserve) and frequency (20 minutes, 3 days per week) and increases with a goal of 70% of heart rate reserve and exercising 60 minutes 4-7 days per week.
|
NO_INTERVENTION: Usual Activity
Participants in this group are not restricted in their activities.
They simply are not guided in their physical activities by the study team.
At the end of the 4 month study period, they will also receive an individualized exercise prescription for personal use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Peak Oxygen Consumption (Peak VO2)
Time Frame: At study Enrollment and 4 months later
|
Cardiopulmonary exercise testing was performed at study enrollment and termination (4 months apart).
Peak VO2 was measured at each time point in each subject and change in peak VO2 over time was calculated.
The change in Peak VO2 was compared between the study arms.
|
At study Enrollment and 4 months later
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life
Time Frame: At study enrollment and 4 months later
|
Quality of life (QOL) questionnaires (Minnesota Living With Heart Failure Questionnaire, MLHF; Quick Inventory of Depressive Symptomatology-Self Report, QIDS-SR16; and the 36-Item Short-Form Health Survey Version 2, SF-36v2) were administered at study enrollment and termination (4 months later). Change over time was compared between study arms. MLHF: range, 0-105; higher scores indicate worse QOL QIDS-SR16: range, 0-27; higher scores indicate more severe depression SF-36v2: 8 subscales and 2 component summary scores; range, 1-100; lower scores indicate more disability; minimal clinically important difference, 3 to 5 points |
At study enrollment and 4 months later
|
Change in Concentration of Brain Natriuretic Peptide (BNP)
Time Frame: At study enrollment and 4 months later
|
Blood will be drawn to evaluate BNP at study enrollment and termination (4 months later).
Change over time was compared between study arms.
|
At study enrollment and 4 months later
|
Change in Scar Volume
Time Frame: At study enrollment and 4 months later
|
Cardiac MRI was performed in all patients without implantable devices/claustrophobia requiring sedation at study enrollment and termination (4 months later).
Scar volume was calculated as total delayed gadolinium enhancement mass at each time interval.
Change over time was compared between study arms.
|
At study enrollment and 4 months later
|
Change in Systolic Function as Measured by Left Ventricular Ejection Fraction.
Time Frame: At study enrollment and 4 months later
|
Echocardiography was performed at study enrollment and termination.
Left ventricular ejection fraction was visually estimated on each echocardiogram.
Change over time was compared by study arm assignment.
|
At study enrollment and 4 months later
|
Change in Degree of Left Ventricular Outflow (LVOT) Obstruction.
Time Frame: At study enrollment and 4 months later
|
Cardiopulmonary exercise testing in combination with echocardiography was performed at study enrollment and termination (4 months).
Peak left ventricular outflow gradients were obtained at rest, with Valsalva and after exercise at each time point.
The change over time was compared by study arm assignment.
|
At study enrollment and 4 months later
|
Change in Maximal Left Ventricle Wall Thickness
Time Frame: At study enrollment and 4 months later
|
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome.
Maximal left ventricle (LV) wall thickness (mm) was measured by cardiac MRI performed at study enrollment and termination (4 months later) and change over time was compared between study arms.
Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.
|
At study enrollment and 4 months later
|
Change in Diastolic Function
Time Frame: At study Enrollment and 4 months later
|
Diastolic function was assessed at each time point and categorized as indeterminate diastolic function, grade I diastolic dysfunction and grade II-III diastolic dysfunction, according to American Society of Echocardiography criteria.
Number of participants whose findings fell into each category was calculated and % change over time was compared between study arms.
Indeterminate indicates diastolic function could not be accurately categorized.
Grade I diastolic dysfunction indicates least severe in terms of outcome measure and Grade III, most severe.
|
At study Enrollment and 4 months later
|
Change in Left Ventricular Mass Index
Time Frame: At study enrollment and 4 months later
|
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome.
Left ventricular mass index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms.
Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.
|
At study enrollment and 4 months later
|
Change in Left Ventricular End Diastolic Volume Index
Time Frame: At study enrollment and 4 months later
|
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome.
Left ventricular end diastolic volume index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms.
Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.
|
At study enrollment and 4 months later
|
Change in Left Ventricular End Systolic Volume Index
Time Frame: At study enrollment and 4 months later
|
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome.
Left ventricular end systolic index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms.
Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.
|
At study enrollment and 4 months later
|
Change in Left Atrial Size
Time Frame: At study enrollment and 4 months later
|
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome.
Left atrial size was measured by echocardiography at study enrollment and termination (4 months later) and change over time was compared between study arms.
|
At study enrollment and 4 months later
|
Change in Left Atrial Volume Index
Time Frame: At study enrollment and 4 months later
|
Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome.
Left atrial volume index was measured by echocardiography at study enrollment and termination (4 months later) and change over time was compared between study arms.
|
At study enrollment and 4 months later
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sara Saberi, MD, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RESET-HCM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiomyopathy, Hypertrophic
-
French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
-
Montreal Heart InstituteCanadian Institutes of Health Research (CIHR)Enrolling by invitationCardiomyopathies | Hypertrophic Cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Familial Hypertrophic CardiomyopathyCanada
-
University of Sao PauloCompletedNon-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyBrazil
-
Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
-
Yonsei UniversityCompletedFamilial Hypertrophic CardiomyopathyKorea, Republic of
-
Hangzhou Valgen Medtech Co., LtdNot yet recruitingObstructive Hypertrophic CardiomyopathyChina
-
China National Center for Cardiovascular DiseasesNot yet recruitingObstructive Hypertrophic Cardiomyopathy
-
Bristol-Myers SquibbNot yet recruitingObstructive Hypertrophic CardiomyopathyKorea, Republic of
-
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.RecruitingObstructive Hypertrophic CardiomyopathyChina
-
Xiang WeiRecruitingNonobstructive Hypertrophic CardiomyopathyChina
Clinical Trials on Exercise training
-
University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Universidade Norte do ParanáCompleted
-
University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Universita di VeronaRecruiting
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
Helse Stavanger HFStavanger Health ResearchCompletedVentricular TachycardiaNorway
-
Hacettepe UniversityCompleted