NCT04504188 · Zoll Medical Corporation
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
(OPT-BB WOMEN)
What this study is about
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 group of participants 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.
View original scientific description
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.
Interventions
DEVICE
Heart Rate Monitor Enhanced Treatment Optimization
Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.
Primary outcome measures
Heart Rate Control
Time frame: 90 days
The primary objective of this study is to document the percentage achievement in effective HR control (average nighttime HR \< 70 bpm) during WCD use in female patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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. Inclusion Criteria 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) are eligible to continue.
Exclusion criteria
- 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 interventional 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.
Where
- Cincinnati, Ohio
- Kingwood, Texas
- McKinney, Texas
- Charleston, West Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2024 · Source of record for eligibility and locations