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Beta Blocker

Heart Rate Optimization for Heart Conditions (OPT-BB WOMEN Trial)

N/A
Recruiting
Led By Valentina Kutyifa, MD PHD
Research Sponsored by Zoll Medical Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a wearable cardioverter defibrillator can help heart failure patients by constantly monitoring their heart rate and adjusting their medication accordingly.

Who is the study for?
This trial is for women over 18 with newly diagnosed cardiomyopathy and heart failure, who have an ejection fraction (EF) ≤ 35%. They must be using a wearable cardioverter defibrillator (WCD) for about 3 months and wear it at least 15 hours per day after the first two weeks. Exclusions include intolerance to beta-blockers, having a pacemaker or ICD, pregnancy, other clinical trials participation, certain heart diseases, permanent atrial fibrillation, or life expectancy under three months.
What is being tested?
The study aims to optimize beta blocker/ivabradine dosage in female patients using continuous heart rate data from their WCDs. The goal is effective heart rate control (<70 bpm at night), compared to past data without this optimization approach.
What are the potential side effects?
While not explicitly stated here, common side effects of increasing beta blockers may include fatigue, cold hands and feet, weight gain; ivabradine can cause bright spots in vision or slow heartbeat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heart Rate Control
Secondary study objectives
Change in Average Nighttime Resting Heart Rate
Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)
Changes in Functional Capacity
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Heart Rate Monitor Enhanced Treatment OptimizationExperimental Treatment1 Intervention
Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD.

Find a Location

Who is running the clinical trial?

Zoll Medical CorporationLead Sponsor
47 Previous Clinical Trials
22,777 Total Patients Enrolled
14 Trials studying Heart Failure
3,223 Patients Enrolled for Heart Failure
Valentina Kutyifa, MD PHDPrincipal InvestigatorUniversity of Rochester

Media Library

BB/ivabradine (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04504188 — N/A
Heart Failure Research Study Groups: Heart Rate Monitor Enhanced Treatment Optimization
Heart Failure Clinical Trial 2023: BB/ivabradine Highlights & Side Effects. Trial Name: NCT04504188 — N/A
BB/ivabradine (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504188 — N/A
~64 spots leftby Nov 2025
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