Assay to Measure Beta Blocker Adherence

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05251974
• Other study ID #: 21145
• Status: Terminated
• Start date: March 2, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: November 2023
• Source: Summa Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Medication Adherence

Intervention

Diagnostic Test:
• Quest beta blocker assay
Blood assay to detect presence of beta blocker medications

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Summa Health System	Quest Diagnostics-Nichols Insitute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission/urgent outpatient visit	Requiring readmission or an urgent outpatient visit for heart failure	30 days
Secondary	Mortality	All-cause mortality during the study period	30 days