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TerminatedNCT05251974Updated Nov 22, 2023

Assay to Measure Beta Blocker Adherence

An observational study in Congestive Heart Failure and Medication Adherence, sponsored by Summa Health System. Terminated at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Summa Health System · Observational

Why this study was terminated
Quest Diagnostics terminated study early - did not want to continue to support single-site study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
27
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the detailed description

Patients admitted to the Summa Akron City campus with a primary diagnosis of heart failure will be invited to participate 1 to 2 days prior to expected discharge. A research nurse with the Summa CRC will enroll patients, obtain informed consent, and perform all study-related blood sample collection. We will collect blood from each enrolled patient up to three times. The first blood sample collection will be obtained just prior to discharge. A second and third blood sample will be collected at the patient's routine 7-day and 30-day post-hospital follow up appointment, respectively. Each blood draw will collect 13mL of blood from each patient, for a total of up to 39mL of blood for the entire study. If the patient is readmitted for heart failure prior to the 7- or 30-day follow up appointment, the subsequent blood draws will be cancelled.

Our enrollment target is 100 patients. Patients admitted to the Summa Akron City campus with a primary diagnosis of heart failure will be invited to participate 1 to 2 days prior to expected discharge. A research nurse with the Summa CRC will enroll patients, obtain informed consent, and perform all study-related blood sample collection. We will collect blood from each enrolled patient up to three times. The first blood sample collection will be obtained just prior to discharge. A second and third blood sample will be collected at the patient's routine 7-day and 30-day post-hospital follow up appointment, respectively. Each blood draw will collect 13mL of blood from each patient, for a total of up to 39mL of blood for the entire study. If the patient is readmitted for heart failure prior to the 7- or 30-day follow up appointment, the subsequent blood draws will be cancelled.

Additionally, study personnel will asses medication adherence at the 7- and 30-day follow up appointments by asking the patient 1) if they took their most recent scheduled dose of their beta blocker, and 2) how often do they miss their scheduled beta blocker dose. Study personnel will also verify medication list and record other cardiology medications used at the 7- and 30-day follow ups. Blood samples will be labeled with the study code and patient DOB, and sent to Quest Diagnostics via courier for analysis. Date/time for each blood sample will be recorded. This information will be recorded on the Quest Visit Worksheet which will be stored in the subjects study binder. For each blood sample, Quest will quantify the amount of beta blocker present, as well as creatinine, and NT-proBNP level present. The patient's providers will be blinded to the assay results until after the 30-day study period has elapsed.

02

Conditions studied

  • Congestive Heart Failure
  • Medication Adherence

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 27 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

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Lead sponsor

Summa Health System is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized with a primary diagnosis of heart failure with reduced ejection fraction at Summa Health - Akron Campus.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No

Groups and cohorts

  • Compliant with beta blocker therapy

    Patients observed to be compliant with beta blocker therapy by blood assay

    Diagnostic Test: Quest beta blocker assay

  • Non-compliant with beta blocker therapy

    Patients observed to be non-compliant with beta blocker therapy by blood assay

    Diagnostic Test: Quest beta blocker assay

Interventions

  • Diagnostic testQuest beta blocker assay

    Blood assay to detect presence of beta blocker medications

06

What researchers measure

Primary outcomes

  1. Readmission/urgent outpatient visit

    Requiring readmission or an urgent outpatient visit for heart failure

    Time frame: 30 days

Secondary outcomes

  1. Mortality

    All-cause mortality during the study period

    Time frame: 30 days

07

Study locations

1 site
  • Summa Health System
    Akron, Ohio 44304, United States
08

References and documents

Individual participant data

Plan to share: No — N/A - no plan to make IPD available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05251974
Lead sponsor
Summa Health System
Collaborators
Quest Diagnostics-Nichols Insitute
Responsible party
Sponsor
First posted
Feb 23, 2022
Start date
Mar 2, 2022
Primary completion
Nov 15, 2023
Completion
Nov 15, 2023
Last update
Nov 22, 2023

Study contacts

Kenneth Varian, MD
principal investigator · Summa Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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