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

A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients

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

Study Overview

• Status: Withdrawn
• Conditions: Dilated Cardiomyopathy
• Intervention / Treatment: Device: Cardea SOLO; Device: ActiGraph wGT3X-BT; Device: Wavelet Wristband

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

4. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Standard; 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.

Device: Cardea SOLO; Participants will be asked to wear everyday for 7 days after the Baseline visit. the monitor attaches to the skin with adhesive and records heart rate and heart rhythm.; Device: ActiGraph wGT3X-BT; Participants will be asked to wear everyday for 2 weeks after the Baseline visit. The wearable tracks activity and the step count during the day.; Device: Wavelet Wristband; Participants will be asked to wear everyday for 2 weeks after the Baseline visit. The wearable measures the activity and the heart rate as measured by PPG sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2max correlation with daily physical activity	Maximal exercise capacity as measured by Max VO2 via CPET correlation with wearable device measures of daily physical activity	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA correlation with daily step count	Correlation between NYHA score and daily step count or maximal walking speed	2 weeks
KCCQ correlation with daily step count	Correlation between KCCQ score and daily step count or maximal walking speed	2 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Matthew T Wheeler, MD PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 41695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No