Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

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Brief Title

Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

Official Title

A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients

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.
    


Study Type

Interventional


Primary Outcome

VO2max correlation with daily physical activity

Secondary Outcome

 NYHA correlation with daily step count

Condition

Dilated Cardiomyopathy

Intervention

Cardea SOLO

Study Arms / Comparison Groups

 Standard
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

August 2017

Completion Date

March 2018

Primary Completion Date

March 2018

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Matthew T Wheeler, MD PhD, , 



Administrative Informations


NCT ID

NCT03207230

Organization ID

41695


Responsible Party

Principal Investigator

Study Sponsor

Stanford University


Study Sponsor

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


Verification Date

August 2019