Kyoto Congestive Heart Failure Study (KCHF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Diastolic; Congestive Heart Failure; Heart Failure, Systolic; Elderly Frail; Guideline Adherence
• Intervention / Treatment: Other: Standard

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 Type: Observational
• Enrollment (Actual): 4056

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan, 606-8507
    • Department of Cardiovascular Medicine, Kyoto University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hospital mortality	1-year

Secondary Outcome Measures

Outcome Measure	Time Frame
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 severe ventricular arrhythmic event during hospitalization	1-year
onset of atrial fibrillation events during hospitalization	1-year
any bradyarrhythmic event during hospitalization	1-year
any stroke during hospitalization	1-year
any cardiac surgery during hospitalization	1-year
any cateter intervention during hospitalization	1-year
any device implantation during hospitalization	1-year
bleeding events during hospitalization (GUSTO definition; moderate to severe)	1-year
adverse drug events during hospitalization	1-year
infectious diseases during hospitalization	1-year
change of BNP at discharge (≧30% compared to BNP at admission )	1-year
worsening renal function at discharge (raise of Cr≧0.3mg/dl compared to Cr at admission )	1-year
usage of guideline recommended medicine during hospitalization	1-year
usage of tolvaptan during hospitalization	1-year

Collaborators and Investigators

• Sponsor: Kyoto University, Graduate School of Medicine
• Investigators: Principal Investigator: Takeshi Kimura, MD, PhD, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School and Faculty of Medicine

Publications and helpful links

General Publications

• Nishimoto Y, Kato T, Morimoto T, Taniguchi R, Yaku H, Inuzuka Y, Tamaki Y, Yamamoto E, Yoshikawa Y, Kitai T, Iguchi M, Kato M, Takahashi M, Jinnai T, Ikeda T, Nagao K, Kawai T, Komasa A, Nishikawa R, Kawase Y, Morinaga T, Su K, Kawato M, Seko Y, Inoko M, Toyofuku M, Furukawa Y, Nakagawa Y, Ando K, Kadota K, Shizuta S, Ono K, Kuwahara K, Ozasa N, Sato Y, Kimura T. Public assistance in patients with acute heart failure: a report from the KCHF registry. ESC Heart Fail. 2022 Jun;9(3):1920-1930. doi: 10.1002/ehf2.13898. Epub 2022 Mar 15.
• Seko Y, Kato T, Morimoto T, Yaku H, Inuzuka Y, Tamaki Y, Ozasa N, Shiba M, Yamamoto E, Yoshikawa Y, Yamashita Y, Kitai T, Taniguchi R, Iguchi M, Nagao K, Jinnai T, Komasa A, Nishikawa R, Kawase Y, Morinaga T, Toyofuku M, Furukawa Y, Ando K, Kadota K, Sato Y, Kuwahara K, Kimura T; KCHF Study Investigators. Newly Diagnosed Infection After Admission for Acute Heart Failure: From the KCHF Registry. J Am Heart Assoc. 2021 Nov 16;10(22):e023256. doi: 10.1161/JAHA.121.023256. Epub 2021 Nov 3.
• Washida K, Kato T, Ozasa N, Morimoto T, Yaku H, Inuzuka Y, Tamaki Y, Seko Y, Yamamoto E, Yoshikawa Y, Kitai T, Yamashita Y, Iguchi M, Nagao K, Kawase Y, Morinaga T, Toyofuku M, Furukawa Y, Ando K, Kadota K, Sato Y, Kuwahara K, Kimura T. Risk Factors and Clinical Outcomes of Nonhome Discharge in Patients With Acute Decompensated Heart Failure: An Observational Study. J Am Heart Assoc. 2021 Aug 3;10(15):e020292. doi: 10.1161/JAHA.120.020292. Epub 2021 Jul 30.
• Nishimoto Y, Kato T, Morimoto T, Yaku H, Inuzuka Y, Tamaki Y, Yamamoto E, Yoshikawa Y, Kitai T, Taniguchi R, Iguchi M, Kato M, Takahashi M, Jinnai T, Ikeda T, Nagao K, Kawai T, Komasa A, Nishikawa R, Kawase Y, Morinaga T, Su K, Kawato M, Seko Y, Inoko M, Toyofuku M, Furukawa Y, Nakagawa Y, Ando K, Kadota K, Shizuta S, Ono K, Kuwahara K, Ozasa N, Sato Y, Kimura T. C-reactive protein at discharge and 1-year mortality in hospitalised patients with acute decompensated heart failure: an observational study. BMJ Open. 2020 Dec 29;10(12):e041068. doi: 10.1136/bmjopen-2020-041068.
• Yaku H, Kato T, Morimoto T, Inuzuka Y, Tamaki Y, Ozasa N, Yamamoto E, Yoshikawa Y, Kitai T, Kato M, Ikeda T, Furukawa Y, Nakagawa Y, Sato Y, Kuwahara K, Kimura T. Risk factors and clinical outcomes of functional decline during hospitalisation in very old patients with acute decompensated heart failure: an observational study. BMJ Open. 2020 Feb 16;10(2):e032674. doi: 10.1136/bmjopen-2019-032674.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: December 28, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 4, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: guideline adherence; congestive heart failure; heart failure, diastolic; heart failure, systolic; elderly frail
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Murmurs; Heart Failure; Heart Failure, Diastolic; Systolic Murmurs; Heart Failure, Systolic
• Other Study ID Numbers: E2311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No