Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

NCT03207230 | Withdrawn

• 1 other identifier: 41695
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NYHA correlation with daily step count

  2 weeks

• KCCQ correlation with daily step count

  2 weeks

Study Arms (1)

Standard

EXPERIMENTAL

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; Device: ActiGraph wGT3X-BT; Device: Wavelet Wristband

Interventions

Cardea SOLO DEVICE

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.

Standard

ActiGraph wGT3X-BT DEVICE

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.

Standard

Wavelet Wristband DEVICE

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.

Standard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Heart failure hospitalization within four weeks prior to enrollment
• Non-cardiac limitation of activity
• \. 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Matthew T Wheeler, MD PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08