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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
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 moreTrial 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.
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Who is running the clinical trial?
Zoll Medical CorporationLead Sponsor
44 Previous Clinical Trials
22,692 Total Patients Enrolled
13 Trials studying Heart Failure
3,224 Patients Enrolled for Heart Failure
Valentina Kutyifa, MD PHDPrincipal InvestigatorUniversity of Rochester
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot take beta-blocker medication due to a known allergy or intolerance.You have a pacemaker.You have a current or past implantable cardioverter defibrillator (ICD).You have a heart condition that you were born with or inherited from your family.You stopped using a wearable cardioverter-defibrillator within the first two weeks of using it.You have a long-term irregular heartbeat (atrial fibrillation).Women who have recently been diagnosed with heart failure and have a low ejection fraction (EF) are eligible for the study.You are not expected to live for more than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Heart Rate Monitor Enhanced Treatment Optimization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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