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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Zoll Medical Corporation
Study ID
NCT04504188
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 8, 2021
Status verified
Jul 2024
Primary completion
Sep 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Heart Rate Monitor Enhanced Treatment Optimization
    Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD.

Primary Outcome Measure

Heart Rate Control [ Time Frame: 90 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
TriHealth Hatton Research InstituteCincinnatiOhio45242
Kesari, MD
Texas Cardiology Associates of HoustonKingwoodTexas77339-
CardioVoyageMcKinneyTexas75020
Abo-Auda, MD
CAMCCharlestonWest Virginia25304-

Find similar trials in Cincinnati, OH

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
TriHealth Hatton Research Institute· Cincinnati, OHTexas Cardiology Associates of Houston· Kingwood, TXCardioVoyage· McKinney, TXCAMC· Charleston, WV

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