Dilated CardiomyopathyMESA-DCMNCT03207230
Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy
A study testing Cardea SOLO, ActiGraph wGT3X-BT and Wavelet Wristband in people with Dilated Cardiomyopathy, run by Stanford University.
Trial summary
Study evaluates the relationships between daily physical activity levels (PAL) and functional capacity (VO2peak) in patients with dilated cardiomyopathy (DCM) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Cardea SOLO, ActiGraph wGT3X-BT and Wavelet Wristband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
About this study
Official title: A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients
Study evaluates the relationships between daily physical activity levels (PAL) and functional capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)
Read the 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.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Cardea SOLO, ActiGraph wGT3X-BT, Wavelet Wristband
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardea SOLODevice
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-BTDevice
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 WristbandDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cardea SOLO; Device: ActiGraph wGT3X-BT; Device: Wavelet Wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (2)
NYHA correlation with daily step count
Correlation between NYHA score and daily step count or maximal walking speed
Measured: 2 weeks
KCCQ correlation with daily step count
Correlation between KCCQ score and daily step count or maximal walking speed
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Funding not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Wheeler, Stanford University
- Investigators
- Matthew T Wheeler, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207230
- Sponsor's protocol ID
- 41695
- Acronym
- MESA-DCM
- Status last verified
- Aug 2019
- First submitted
- 27 Jun 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients
- ClinicalTrials.gov ID
- NCT03207230
- Acronym / sponsor ID
- MESA-DCM / 41695
- Conditions
- Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Standard | Experimental | Device: Cardea SOLO, Device: ActiGraph wGT3X-BT, Device: Wavelet WristbandAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females, 18-75 years of age
- Diagnosis of dilated cardiomyopathy
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardea SOLOParticipants 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 | Standard |
| ActiGraph wGT3X-BTParticipants 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 | Standard |
| Wavelet WristbandParticipants 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. | Device | Standard |
Primary outcome
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
2 secondary outcomes
NYHA correlation with daily step count
Time frame: 2 weeks
KCCQ correlation with daily step count
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew T Wheeler, MD PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Cardea SOLO, ActiGraph wGT3X-BT and Wavelet Wristband in people with Dilated Cardiomyopathy, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max correlation with daily physical activity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.