Kyoto Congestive Heart Failure Study

Congestive Heart Failure Clinical Trial

— KCHF  

Official title:

Kyoto Congestive Heart Failure Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334891
• Other study ID #: E2311
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Elderly Frail
• Guideline Adherence
• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Systolic Murmurs

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