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New treatment option for Cardiomyopathies
Official title Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
ClinicalTrials.gov ID: NCT04504188
What this study is testing
- What it's testing
- The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR \< 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical control.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- for Screening Phase:
- Female patients with newly diagnosed (never hospitalized for HF in the last 30 days prior to enrollment) ischemic or non-ischemic cardiomyopathy and...
- Patients prescribed the WCD for an intended 90 ± 14 days of use.
- Patients have used the WCD for no more than 14 days from the day of consent.
- Patients 18 years of age or older at the time of consent. for Continuation Phase: -After the first 2 weeks of WCD wear, only actively wearing...
You likely can't join if
- for Screening Phase:
- Patients with a known contraindication or intolerance to beta-blocker therapy.
- Patients with permanent atrial fibrillation.
- Patients who have a pacemaker.
- Patients with a current or prior implantable cardioverter defibrillator (ICD).
- Patients who are self-reporting to be pregnant.
See the full eligibility criteria
- for Screening Phase:
- Female patients with newly diagnosed (never hospitalized for HF in the last 30 days prior to enrollment) ischemic or non-ischemic cardiomyopathy and an EF ≤ 35% at the time of WCD prescription.
- Patients prescribed the WCD for an intended 90 ± 14 days of use.
- Patients have used the WCD for no more than 14 days from the day of consent.
- Patients 18 years of age or older at the time of consent. for Continuation Phase: -After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours/day)...
- for Screening Phase:
- Patients with a known contraindication or intolerance to beta-blocker therapy.
- Patients with permanent atrial fibrillation.
- Patients who have a pacemaker.
- Patients with a current or prior implantable cardioverter defibrillator (ICD).
- Patients who are self-reporting to be pregnant.
- Patients with known congenital or inherited heart disease.
- Patients participating in another treatment clinical trial.
- Patients not expected to live longer than 3 months. Exclusion Criteria for Continuation Phase: -Patients ending WCD use within the first two weeks of use.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
- Kingwood, Texas, United States
- McKinney, Texas, United States
- Charleston, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States; Kingwood, Texas, United States; McKinney, Texas, United States; Charleston, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.