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
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.
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.
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.
Browse Heart Failure studies →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.
Patients hospitalized with a primary diagnosis of heart failure with reduced ejection fraction at Summa Health - Akron Campus.
Exclusion Criteria:
Patients observed to be compliant with beta blocker therapy by blood assay
Diagnostic Test: Quest beta blocker assay
Patients observed to be non-compliant with beta blocker therapy by blood assay
Diagnostic Test: Quest beta blocker assay
Blood assay to detect presence of beta blocker medications
Readmission/urgent outpatient visit
Requiring readmission or an urgent outpatient visit for heart failure
Time frame: 30 days
Mortality
All-cause mortality during the study period
Time frame: 30 days
Plan to share: No — N/A - no plan to make IPD available.
No publications or documents are linked to this record.
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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