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

Primary Purpose

Dilated Cardiomyopathy

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Cardea SOLO

ActiGraph wGT3X-BT

Wavelet Wristband

About this trial

This is an interventional other trial for Dilated Cardiomyopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Standard

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

NYHA correlation with daily step count

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

KCCQ correlation with daily step count

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

Full Information

NCT ID

NCT03207230

First Posted

June 27, 2017

Last Updated

August 9, 2019

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03207230

Brief Title

Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

Acronym

MESA-DCM

Official Title

A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Funding not secured

Study Start Date

August 2017 (Anticipated)

Primary Completion Date

March 2018 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dilated Cardiomyopathy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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).

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Cardea SOLO

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

ActiGraph wGT3X-BT

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Wavelet Wristband

Intervention Description

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.

Primary Outcome Measure Information:

Title

VO2max correlation with daily physical activity

Description

Maximal exercise capacity as measured by Max VO2 via CPET correlation with wearable device measures of daily physical activity

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

NYHA correlation with daily step count

Description

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

Time Frame

2 weeks

Title

KCCQ correlation with daily step count

Description

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

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew T Wheeler, MD PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

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