Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorZoll Medical Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Heart Rate Monitor Enhanced Treatment Optimization
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov