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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
OPT-BB WOMEN Trial 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.
Eligible Conditions
- Heart Failure
- Cardiomyopathy
OPT-BB WOMEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart Rate Control
Secondary outcome measures
Change in Average Nighttime Resting Heart Rate
Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)
Changes in Functional Capacity
+2 moreOPT-BB WOMEN 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.
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Who is running the clinical trial?
Zoll Medical CorporationLead Sponsor
41 Previous Clinical Trials
21,771 Total Patients Enrolled
13 Trials studying Heart Failure
3,467 Patients Enrolled for Heart Failure
Valentina Kutyifa, MD PHDPrincipal InvestigatorUniversity of Rochester
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have enrolled in this scientific experiment?
"Affirmative. Clinicaltrials.gov states that the trial, originally launched on March 8th 2021, is actively enrolling participants at this time. It requires 300 volunteers from two separate locations to complete the study."
Answered by AI
Are there available openings for this clinical experiment right now?
"Affirmative. Clinicaltrials.gov hosts information that attests to the fact that this clinical trial is searching for participants, as it was first posted on March 8th 2021 and updated most recently on July 12th 2022. The study requires 300 people at two sites."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Texas Cardiology Associates of Houston
What portion of applicants met pre-screening criteria?
Met criteria
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