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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02334891
Other study ID # E2311
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date March 30, 2021

Study information

Verified date September 2021
Source Kyoto University, Graduate School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4056
Est. completion date March 30, 2021
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Intervention

Other:
Standard
Standard management

Locations

Country Name City State
Japan Department of Cardiovascular Medicine, Kyoto University Hospital Kyoto

Sponsors (1)

Lead Sponsor Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

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