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Trial record 22 of 157 for:    Idiopathic Dilated Cardiomyopathy

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

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ClinicalTrials.gov Identifier: NCT03207230
Recruitment Status : Withdrawn (Funding not secured)
First Posted : July 2, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Wheeler, Stanford University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018


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.




Primary Outcome Measures :
  1. VO2max correlation with daily physical activity [ Time Frame: 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 [ Time Frame: 2 weeks ]
    Correlation between NYHA score and daily step count or maximal walking speed

  2. KCCQ correlation with daily step count [ Time Frame: 2 weeks ]
    Correlation between KCCQ score and daily step count or maximal walking speed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207230


Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Matthew T Wheeler, MD PhD Stanford University

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Responsible Party: Matthew Wheeler, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03207230     History of Changes
Other Study ID Numbers: 41695
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly