Recruiting

Beta Blocker

Sponsor:

Zoll Medical Corporation

Code:

NCT04504188

Conditions

Cardiomyopathies

Heart Failure

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Heart Rate Monitor Enhanced Treatment Optimization

Study Details

Brief 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 dosage, as compared to a prior historical control.

Conditions

Cardiomyopathies

Heart Failure

Study ID

NCT04504188

Start date

Mar 8, 2021

Status verified date

Jul, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria for Screening Phase:

  • 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.

Inclusion Criteria for Continuation Phase:

-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.

Exclusion Criteria for Screening Phase:

  • 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.
  • Patients participating in another interventional clinical trial.
  • Patients not expected to live longer than 3 months.

Exclusion Criteria for Continuation Phase:

-Patients ending WCD use within the first two weeks of use.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Heart Rate Monitor Enhanced Treatment Optimization

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.

Primary outcome measure

  • Heart Rate Control [ Time Frame: 90 days ]

Central Contacts and Locations

Locations

TriHealth Hatton Research Institute

Recruiting

Cincinnati, Ohio, United States, 45242

CardioVoyage

Recruiting

McKinney, Texas, United States, 75020

More Information

Sponsor

Zoll Medical Corporation

Last update posted

Jul 24, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zoll Medical Corporation on 2024-07-24.