Health TrialsbyHealthPanel

Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator

ConditionsCardiomyopathiesHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorZoll Medical Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Heart Rate Monitor Enhanced Treatment Optimization

    Device

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Heart Rate Monitor Enhanced Treatment OptimizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90 days

Secondary outcomes

1

Heart Rate Control in Ischemic vs. Non-ischemic Patients

To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients

Time frame
90 days
2

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.

Time frame
90 days
3

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)

Time frame
90 days
4

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)

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zoll Medical Corporation

Lead sponsor

Source ClinicalTrials.gov
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