NCT02334891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,056

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

4.4 years

First QC Date

December 28, 2014

Last Update Submit

September 4, 2021

Conditions

Congestive Heart FailureHeart Failure, DiastolicHeart Failure, SystolicElderly FrailGuideline Adherence

Keywords

congestive heart failureheart failure, diastolicheart failure, systolicelderly frailguideline adherence

Outcome Measures

Primary Outcomes (1)

  • hospital mortality

    1-year

Secondary Outcomes (17)

  • 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

  • +12 more secondary outcomes

Interventions

StandardOTHER

Standard management

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Medicine, Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Related Publications (7)

  • Nishikawa R, Kato T, Morimoto T, Yaku H, Inuzuka Y, Tamaki Y, Yamamoto E, Ozasa N, Tada T, Sakamoto H, Seko Y, Shiba M, Yoshikawa Y, Yamashita Y, Kitai T, Taniguchi R, Iguchi M, Nagao K, Kawai T, Komasa A, Kawase Y, Morinaga T, Toyofuku M, Furukawa Y, Ando K, Kadota K, Sato Y, Kuwahara K, Kimura T; KCHF Study Investigators. The characteristics and outcomes in patients with acute heart failure who used tolvaptan: from KCHF registry. ESC Heart Fail. 2023 Oct;10(5):3141-3151. doi: 10.1002/ehf2.14494. Epub 2023 Aug 29.

    PMID: 37644779DERIVED

  • Aida K, Nagao K, Kato T, Yaku H, Morimoto T, Inuzuka Y, Tamaki Y, Yamamoto E, Yoshikawa Y, Kitai T, Taniguchi R, Iguchi M, Kato M, Takahashi M, Jinnai T, Kawai T, Komasa A, Nishikawa R, Kawase Y, Morinaga T, Su K, Kawato M, Seko Y, Inada T, Inoko M, Toyofuku M, Furukawa Y, Nakagawa Y, Ando K, Kadota K, Shizuta S, Ono K, Sato Y, Kuwahara K, Ozasa N, Kimura T. Prognostic Value of the Severity of Clinical Congestion in Patients Hospitalized for Decompensated Heart Failure: Findings From the Japanese KCHF Registry. J Card Fail. 2023 Aug;29(8):1150-1162. doi: 10.1016/j.cardfail.2023.01.003. Epub 2023 Jan 21.

    PMID: 36690136DERIVED

  • 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.

    PMID: 35289117DERIVED

  • 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.

    PMID: 34730004DERIVED

  • 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.

    PMID: 34325523DERIVED

  • 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.

    PMID: 33376169DERIVED

  • 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.

    PMID: 32066601DERIVED

MeSH Terms

Conditions

Heart FailureHeart Failure, DiastolicHeart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Takeshi Kimura, MD, PhD

    Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School and Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 28, 2014

First Posted

January 8, 2015

Study Start

October 1, 2014

Primary Completion

March 1, 2019

Study Completion

March 30, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

JP(1)