RecruitingNot ApplicableNCT04504188

Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator

Sponsor

Zoll Medical Corporation

Enrollment

300 participants

Start Date

Mar 8, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure Cardiomyopathies

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether using a wearable heart device (called a wearable cardioverter defibrillator, or WCD — a vest that can shock the heart if it stops) helps doctors find the right dose of a heart failure medication (beta-blocker) more quickly in women with newly diagnosed heart failure and a weakly pumping heart. **You may be eligible if...** - You are a woman - You have been recently diagnosed with heart failure (not hospitalized for it in the last 30 days) - Your heart's pumping function is 35% or less (low ejection fraction) - You have been prescribed the WCD vest and have been wearing it for 14 days or fewer - You are 18 or older **You may NOT be eligible if...** - You have had heart failure for a long time and have already been hospitalized for it - You have conditions that prevent wearing or using the WCD vest - You have a permanent implanted defibrillator - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHeart 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.