A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients

Stanford University0 sitesAugust 2017

ConditionsDilated Cardiomyopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dilated Cardiomyopathy
Sponsor: Stanford University
Primary Endpoint: VO2max correlation with daily physical activity
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Study evaluates the relationships between daily physical activity levels (PAL) and functional capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)

Detailed Description

The study will evaluate the daily physical activity with the use of activity monitor, heart rate monitor and event monitor in patients with dilated cardiomyopathy (DCM). These wearables track the heart rate, heart rhythm, tracks activity and step count. The VO2 peak will be measured via the exercise test.

Registry

clinicaltrials.gov

Start Date

August 2017

End Date

March 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Matthew Wheeler

Clinical Assistant Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

•Males and females, 18-75 years of age
•Diagnosis of dilated cardiomyopathy
•(Unexplained left ventricular enlargement (left ventricular end diastolic dimension (LVEDD) \>95th percentile for gender and height by echo or MRI)
•(Left ventricular ejection fraction (LVEF) less than 50%)
•CPET within 14 days prior to baseline visit with no intervening change in therapy
•Echocardiogram or cardiac MRI within 1 year prior to baseline
•Able to walk \>100ft without limitation
•More than 30 minutes of exercise per week for at least 3 months prior to study enrollment, and plan to continue exercising for the next two weeks (duration of study).
•Ability to provide informed consent and willingness to complete the study (including weekly phone follow-up)

Exclusion Criteria

•Heart failure hospitalization within four weeks prior to enrollment
•Non-cardiac limitation of activity
•Prior exercise-induced syncope or exercise-induced sudden death
•Primary exercise mode is swimming or stationary biking
•Participation in competitive or high intensity exercise against medical advice
•Implantable Cardiverter Defibrillator (ICD) placement in the 2 months prior to enrollment
•Plan for surgery, device implantation, or significant change in clinical management during the two weeks of the study