Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy (MESA-DCM)

Stanford University

Status: Withdrawn

Conditions: Dilated Cardiomyopathy

Treatments: Device: Wavelet Wristband; Device: ActiGraph wGT3X-BT; Device: Cardea SOLO

Study type: Interventional

Funder types: Other

Identifiers

NCT03207230

41695

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females, 18-75 years of age

2. 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%)

3. CPET within 14 days prior to baseline visit with no intervening change in therapy

4. Echocardiogram or cardiac MRI within 1 year prior to baseline

5. Able to walk >100ft without limitation

6. 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).

7. Ability to provide informed consent and willingness to complete the study (including weekly phone follow-up)

Exclusion criteria

1. Heart failure hospitalization within four weeks prior to enrollment

2. Non-cardiac limitation of activity

3. Prior exercise-induced syncope or exercise-induced sudden death 5. Primary exercise mode is swimming or stationary biking 6. Participation in competitive or high intensity exercise against medical advice 7. Implantable Cardiverter Defibrillator (ICD) placement in the 2 months prior to enrollment 8. Plan for surgery, device implantation, or significant change in clinical management during the two weeks of the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Standard

Experimental group

Description:

All participants will perform the CPET at Baseline visit and will be provided with the Cardea SOLO, ActiGraph wGT3X-BT and Wavelet Wristband. The participants will be asked to response to KCCQ and Stanford 7 day recall surveys.

Treatment:

Device: ActiGraph wGT3X-BT

Device: Wavelet Wristband

Device: Cardea SOLO