Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
27 participants
OBSERVATIONAL
2022-03-02
2023-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Compliant with beta blocker therapy
Patients observed to be compliant with beta blocker therapy by blood assay
Quest beta blocker assay
Blood assay to detect presence of beta blocker medications
Non-compliant with beta blocker therapy
Patients observed to be non-compliant with beta blocker therapy by blood assay
Quest beta blocker assay
Blood assay to detect presence of beta blocker medications
Interventions
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Quest beta blocker assay
Blood assay to detect presence of beta blocker medications
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
89 Years
ALL
No
Sponsors
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Quest Diagnostics-Nichols Insitute
INDUSTRY
Summa Health System
OTHER
Responsible Party
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Principal Investigators
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Kenneth Varian, MD
Role: PRINCIPAL_INVESTIGATOR
Summa Health System
Locations
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Summa Health System
Akron, Ohio, United States
Countries
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Other Identifiers
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21145
Identifier Type: -
Identifier Source: org_study_id