CardiomyopathiesOPT-BB WOMENNCT04504188
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
A study testing Heart Rate Monitor Enhanced Treatment Optimization in people with Cardiomyopathies and Heart Failure, run by Zoll Medical Corporation at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiomyopathies, Heart Failure
- What is being tested?
- Heart Rate Monitor Enhanced Treatment Optimization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Mar 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients prescribed the WCD for an intended 90 ± 14 days of use.
- Patients have used the WCD for no more than 14 days from the day of consent.
- Patients 18 years of age or older at the time of consent.
- -After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours/day) are eligible to continue.
Who cannot join
- Patients with a known contraindication or intolerance to beta-blocker therapy.
- Patients with permanent atrial fibrillation.
- Patients who have a pacemaker.
- Patients with a current or prior implantable cardioverter defibrillator (ICD).
- Patients who are self-reporting to be pregnant.
- Patients with known congenital or inherited heart disease.
Show all 9Show fewer
- Patients participating in another interventional clinical trial.
- Patients not expected to live longer than 3 months.
- -Patients ending WCD use within the first two weeks of use.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 2 recruiting
- Terminated
CAMC
Charleston, West Virginia, 25304
- Recruiting
TriHealth Hatton Research Institute
Cincinnati, Ohio, 45242
Kesari, MD
- Terminated
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339
- Recruiting
CardioVoyage
McKinney, Texas, 75020
Abo-Auda, MD
About this study
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.
Read the detailed description
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.
Adult female patients (18 years or older) who are prescribed the wearable cardioverter defibrillator (WCD) for 3 months for ischemic or non-ischemic cardiomyopathy with a low ejection fraction.
Subjects will wear an FDA-approved WCD with a 3 month follow-up period. 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.
Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (<70 bpm) by the end of WCD use.
- Conditions
- Cardiomyopathies, Heart Failure
- Being tested
- Heart Rate Monitor Enhanced Treatment Optimization
- Medical subject headings
- Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Monitor Enhanced Treatment OptimizationDevice
Also called LifeVest Wearable Cardioverter Defibrillator
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.
| Study group | Role | What they receive |
|---|---|---|
| Heart Rate Monitor Enhanced Treatment Optimization | Experimental | Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. Receives: Device: Heart Rate Monitor Enhanced Treatment Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Control
The primary objective of this study is to document the percentage achievement in effective HR control (average nighttime HR < 70 bpm) during WCD use in female patients.
Measured: 90 days
Secondary outcomes (5)
Heart Rate Control in Ischemic vs. Non-ischemic Patients
To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients
Measured: 90 days
Change in Average Nighttime Resting Heart Rate
Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use.
Measured: 90 days
Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
To observe changes in quality of life over the course of WCD use using the KCCQ-12 Questionnaire. Higher scores on the KCCQ reflect better health status (range 0-100)
Measured: 90 days
Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)
To observe changes in quality of life over the course of WCD use using the EQ-5D-5L Questionnaire. Higher scores on the EQ-5D-5L reflect better health status (range 0-100)
Measured: 90 days
Changes in Functional Capacity
To observe changes in functional capacity as measured by average daily step count over the course of WCD use.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start8 Mar 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will wear an FDA-approved WCD with a 3 month follow-up period. 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. Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (\<70 bpm) by the end of WCD use.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valentina Kutyifa, MD PHD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504188
- Sponsor's protocol ID
- 90D0229
- Acronym
- OPT-BB WOMEN
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2020
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
- ClinicalTrials.gov ID
- NCT04504188
- Acronym / sponsor ID
- OPT-BB WOMEN / 90D0229
- Conditions
- Cardiomyopathies, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Adult female patients (18 years or older) who are prescribed the wearable cardioverter defibrillator (WCD) for 3 months for ischemic or non-ischemic cardiomyopathy with a low ejection fraction.
Subjects will wear an FDA-approved WCD with a 3 month follow-up period. 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.
Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (<70 bpm) by the end of WCD use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will wear an FDA-approved WCD with a 3 month follow-up period. 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. Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (<70 bpm) by the end of WCD use.
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Monitor Enhanced Treatment Optimization | Experimental | Device: Heart Rate Monitor Enhanced Treatment OptimizationSubjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patients prescribed the WCD for an intended 90 ± 14 days of use.
- Patients have used the WCD for no more than 14 days from the day of consent.
- Patients 18 years of age or older at the time of consent.
- -After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours/day) are eligible to continue.
Key exclusion criteria (9 listed)
- Patients with a known contraindication or intolerance to beta-blocker therapy.
- Patients with permanent atrial fibrillation.
- Patients who have a pacemaker.
- Patients with a current or prior implantable cardioverter defibrillator (ICD).
- Patients who are self-reporting to be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate Monitor Enhanced Treatment OptimizationAlso: LifeVest Wearable Cardioverter DefibrillatorHeart 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. | Device | Heart Rate Monitor Enhanced Treatment Optimization |
Primary outcome
Heart Rate Control
Time frame: 90 days
The primary objective of this study is to document the percentage achievement in effective HR control (average nighttime HR < 70 bpm) during WCD use in female patients.
5 secondary outcomes
Heart Rate Control in Ischemic vs. Non-ischemic Patients
Time frame: 90 days
Change in Average Nighttime Resting Heart Rate
Time frame: 90 days
Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: 90 days
Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)
Time frame: 90 days
Changes in Functional Capacity
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiomyopathies
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingPhase 2
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Arrhythmogenic Cardiomyopathy
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruitingObservational study
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Kutyifa, MD PHD principal investigator
University of Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Rate Monitor Enhanced Treatment Optimization in people with Cardiomyopathies and Heart Failure, run by Zoll Medical Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Osz (412-968-3333, mosz@zoll.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Control (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.