KCHF: Kyoto Congestive Heart Failure Study

Sponsor
Kyoto University, Graduate School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02334891
Collaborator
(none)
4,056
1
77.9
52

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
4056 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Kyoto Congestive Heart Failure Study
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 30, 2021

Outcome Measures

Primary Outcome Measures

  1. hospital mortality [1-year]

Secondary Outcome Measures

  1. functional level at discharge measured by NYHA classification [1-year]

  2. improvement of dyspnea level at discharge measured by Likert scale [1-year]

  3. walking ability at discharge categorized by ambulatory, wheelchair (outdoor only), wheelchair (outdoor and indoor), bedridden [1-year]

  4. any severe ventricular arrhythmic event during hospitalization [1-year]

  5. onset of atrial fibrillation events during hospitalization [1-year]

  6. any bradyarrhythmic event during hospitalization [1-year]

  7. any stroke during hospitalization [1-year]

  8. any cardiac surgery during hospitalization [1-year]

  9. any cateter intervention during hospitalization [1-year]

  10. any device implantation during hospitalization [1-year]

  11. bleeding events during hospitalization (GUSTO definition; moderate to severe) [1-year]

  12. adverse drug events during hospitalization [1-year]

  13. infectious diseases during hospitalization [1-year]

  14. change of BNP at discharge (≧30% compared to BNP at admission ) [1-year]

  15. worsening renal function at discharge (raise of Cr≧0.3mg/dl compared to Cr at admission ) [1-year]

  16. usage of guideline recommended medicine during hospitalization [1-year]

  17. usage of tolvaptan during hospitalization [1-year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Cardiovascular Medicine, Kyoto University Hospital Kyoto Japan 606-8507

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT02334891
Other Study ID Numbers:
  • E2311
First Posted:
Jan 8, 2015
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Keywords provided by Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021