Study Stopped
Quest Diagnostics terminated study early - did not want to continue to support single-site study
Assay to Measure Beta Blocker Adherence
The Effect of Medication Compliance, Verified With Medication Level Testing, on Unplanned Hospital Readmission or Urgent Outpatient Visit in Patients With Acute Decompensated Heart Failure
1 other identifier
observational
27
1 country
1
Brief Summary
This study will assess the feasibility and efficacy of using serum assay developed by Quest Diagnostics to detect the presence of beta blockers, specifically carvedilol and metoprolol succinate, in patients with heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedStudy Start
First participant enrolled
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2023
CompletedNovember 22, 2023
November 1, 2023
1.7 years
February 11, 2022
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Readmission/urgent outpatient visit
Requiring readmission or an urgent outpatient visit for heart failure
30 days
Secondary Outcomes (1)
Mortality
30 days
Study Arms (2)
Compliant with beta blocker therapy
Patients observed to be compliant with beta blocker therapy by blood assay
Non-compliant with beta blocker therapy
Patients observed to be non-compliant with beta blocker therapy by blood assay
Interventions
Blood assay to detect presence of beta blocker medications
Eligibility Criteria
Patients hospitalized with a primary diagnosis of heart failure with reduced ejection fraction at Summa Health - Akron Campus.
You may qualify if:
- Age 18-89
- Admitted for primary diagnosis of heart failure with reduced ejection fraction
- Prescribed carvedilol or metoprolol succinate for beta blocker therapy
- Will be following up at 95 Arch St. Clinic
You may not qualify if:
- Under age 18/over age 89
- Patients that plan to follow up somewhere other than the 95 Arch St. Clinic
- Patients with prior heart transplant or a left ventricular assist device
- Patient is unable to provide consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Summa Health Systemlead
- Quest Diagnostics-Nichols Insitutecollaborator
Study Sites (1)
Summa Health System
Akron, Ohio, 44304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Varian, MD
Summa Health System
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 23, 2022
Study Start
March 2, 2022
Primary Completion
November 15, 2023
Study Completion
November 15, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
N/A - no plan to make IPD available.