Relationship between the Administration of Tolvaptan and Rehospitalization in Patients with a History of Hospitalization Due to Heart Failure -A retrospective cohort study conducted using a DPC database

Not Applicable

• Conditions: Heart Failure

• Registration Number: JPRN-UMIN000029431
• Lead Sponsor: Hyogo Prefectural Amagasaki General Medical Center

Brief Summary

A total of 26,181 patients who were hospitalized more than twice because of heart failure (HF) during the period between April 1, 2008, and March 31, 2017, were selected for this study. The patients were divided into Case 1, Case 2, Hcont, and Scont cohorts, each having 719, 1,427, 278, and 6,185, patients, respectively. As the number of patients enrolled in the Hcont cohort was not sufficient to perform analysis, comparison between the Case 1 and Hcont cohorts, which was one of the primary endpoints, was not performed. The number of patients who were re-hospitalized because of HF after I date was obviously higher in the Case 1 cohort (402/719) than in the Case 2 (472/1,427) and Scont (1,830/6,185) cohorts. Patients in the Case 1 and Scont cohorts were matched using predetermined matching factors. The hazard ratio between the matched Case 1 and Scont cohorts (each with 719 patients) was 1.85 (95% CI 1.57-2.18, p<0.001), indicating a statistically significantly higher risk for re-hospitalization in the Case 1 cohort. This result may have been driven by the limited information on patients in the database, such as the absence of laboratory data and insufficiency of data on the clinical seriousness of HF. Considering the circumstance, tolvaptan was used in the re-hospitalized and critical patients, and it was difficult to adjust the factors to continue this drug, which has a high reimbursement price. As the primary endpoint in this study could not be confirmed to be relevant, we decided to not analyze the secondary endpoints and therefore discontinued the study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who were aged less than 20 years at the time of the Index date Patients who were not prescribed a diuretic within 30 days after the Index date Patients who received dialysis (medical treatment of classification No. J038, and J042 by qualified medical personal) within 30 days after the Index date Patients where the Index date is March 2, 2017 or late Patients with no NYHA classified data within 1 year before the Index date Patients who were diagnosed with acute or recurrent myocardial infarction (ICD 10; I2[12]), and unstable angina (ICD 10; I200) within 30 days before the Index date Patients who were diagnosed with malignant neoplasm (ICD 10; C), liver failure (K704, K72), or an infectious disease with a poor prognosis such as HIV (ICD 10; B2 [01234]) within 1800 days before the Index date. Patients who were rehospitalized due to HF within 30 days after the Index date

Study & Design

• Study Type: Others,meta-analysis etc
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Period until first rehospitalization due to HF after the index date in the Case 1 group and the matched Hcont group and Scont group.

Secondary Outcome Measures

Name	Time	Method
The period until first rehospitalization due to HF after the Index date in the Case 2 group and the matched Hcont group and Scont group. The period until first all cause rehospitalization after the index date in the Case 1 and Case 2 group and respective matched Hcont and Scont group.