Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

Not Applicable

Withdrawn

• Conditions: Dilated Cardiomyopathy
• Interventions: Device: Cardea SOLO; Device: ActiGraph wGT3X-BT; Device: Wavelet Wristband

• Registration Number: NCT03207230
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Study Start: 2017-08
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard	Cardea SOLO	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.
Standard	ActiGraph wGT3X-BT	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.
Standard	Wavelet Wristband	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.

Primary Outcome Measures

Name	Time	Method
VO2max correlation with daily physical activity	2 weeks	Maximal exercise capacity as measured by Max VO2 via CPET correlation with wearable device measures of daily physical activity

Secondary Outcome Measures

Name	Time	Method
KCCQ correlation with daily step count	2 weeks	Correlation between KCCQ score and daily step count or maximal walking speed
NYHA correlation with daily step count	2 weeks	Correlation between NYHA score and daily step count or maximal walking speed