Kyoto Congestive Heart Failure Study

Completed

• Conditions: Congestive Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic; Elderly Frail; Guideline Adherence

• Registration Number: NCT02334891
• Lead Sponsor: Kyoto University, Graduate School of Medicine

Brief Summary

The purpose of this study is to investigate the patient characteristics, selection of treatment, and factors associated with clinical outcomes in Japanese patients with acutely decompensated congestive heart failure.

Detailed Description

Congestive heart failure (CHF) has been markedly increasing in Japan due to the rapid aging of the society and the Westernization of lifestyle that facilitates the development of coronary artery disease. The prognosis of patients with CHF still remains poor, despite the recent advances in medical and surgical treatment. Elderly heart failure patients with preserved ejection and multiple comorbidity may account for significant portion among CHF patients in the real world clinical practice, however; most of previous prospective cohort studies excluded these patients. The KCHF registry, an all-comer, prospective, multicenter registry, was designed to investigate all patients who admitted to the hospital due to acutly decompensated CHF. The aim of this study was to clarify the patients characteristics , selection of treatment, and prognosis of patients with acutly decompensated CHF in the real-world clinical practice in Japan.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-28
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-08
• Primary Completion: 2019-03
• Study Completion: 2021-03-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-04
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4056

Inclusion Criteria

• All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham criteria
• Patients who underwent heart failure treatment including intravenus drug

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hospital mortality	1-year

Secondary Outcome Measures

Name	Time	Method
functional level at discharge measured by NYHA classification	1-year
improvement of dyspnea level at discharge measured by Likert scale	1-year
walking ability at discharge categorized by ambulatory, wheelchair (outdoor only), wheelchair (outdoor and indoor), bedridden	1-year
any stroke during hospitalization	1-year
bleeding events during hospitalization (GUSTO definition; moderate to severe)	1-year
any severe ventricular arrhythmic event during hospitalization	1-year
onset of atrial fibrillation events during hospitalization	1-year
change of BNP at discharge (≧30% compared to BNP at admission )	1-year
usage of guideline recommended medicine during hospitalization	1-year
usage of tolvaptan during hospitalization	1-year
worsening renal function at discharge (raise of Cr≧0.3mg/dl compared to Cr at admission )	1-year
any bradyarrhythmic event during hospitalization	1-year
any cardiac surgery during hospitalization	1-year
any device implantation during hospitalization	1-year
adverse drug events during hospitalization	1-year
infectious diseases during hospitalization	1-year
any cateter intervention during hospitalization	1-year

Trial Locations

Locations (1)

Department of Cardiovascular Medicine, Kyoto University Hospital; 🇯🇵 Kyoto, Japan