MESA-DCM: Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

• Sponsor: Stanford University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03207230
• Collaborator: (none)
• Enrollment: 0
• Arm: 1
• Anticipated Duration (Months): 7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dilated Cardiomyopathy	Device: Cardea SOLO; Device: ActiGraph wGT3X-BT; Device: Wavelet Wristband	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants enrolled in the study will receive the wearables and will be evaluated for the relationship between daily physical activity levels and functional capacity (VO2 peak).All participants enrolled in the study will receive the wearables and will be evaluated for the relationship between daily physical activity levels and functional capacity (VO2 peak).
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients
• Anticipated Study Start Date: Aug 1, 2017
• Anticipated Primary Completion Date: Mar 1, 2018
• Anticipated Study Completion Date: Mar 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. NYHA correlation with daily step count [2 weeks]

   Correlation between NYHA score and daily step count or maximal walking speed

2. KCCQ correlation with daily step count [2 weeks]

   Correlation between KCCQ score and daily step count or maximal walking speed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%)

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

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

3. Able to walk >100ft without limitation

4. 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).

5. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthew Wheeler, Clinical Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03207230
• Other Study ID Numbers: 41695
• First Posted: Jul 2, 2017
• Last Update Posted: Aug 13, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated

Study Results

No Results Posted as of Aug 13, 2019