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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
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
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women who have recently been diagnosed with heart failure and have a low ejection fraction (EF) are eligible for the study.

OPT-BB WOMEN Trial 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

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 more

OPT-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.

Find a Location

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

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

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
~73 spots leftby Apr 2025