Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

— MESA-DCM  

Official title:

A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03207230
• Other study ID #: 41695
• Status: Withdrawn
• Phase: N/A
• Start date: August 2017
• Est. completion date: March 2018

Study information

• Verified date: August 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NYHA correlation with daily step count	Correlation between NYHA score and daily step count or maximal walking speed	2 weeks
Secondary	KCCQ correlation with daily step count	Correlation between KCCQ score and daily step count or maximal walking speed	2 weeks