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临床试验/NCT05251974
NCT05251974终止不适用

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

Summa Health System1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
1
主要终点
Readmission/urgent outpatient visit

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Readmission/urgent outpatient visit

时间窗: 30 days

Requiring readmission or an urgent outpatient visit for heart failure

次要结局

  • Mortality(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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