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Completed

NCT Number: NCT02334891

Kyoto Congestive Heart Failure Study

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Elderly Frail Guideline Adherence Heart Diseases Heart Failure Heart Failure, Diastolic Heart Failure, Systolic

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiovascular Medicine, Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard

Other

Standard management

Primary outcomes

  1. hospital mortality

    Time frame: 1-year

Secondary outcomes

  1. functional level at discharge measured by NYHA classification

    Time frame: 1-year

  2. improvement of dyspnea level at discharge measured by Likert scale

    Time frame: 1-year

  3. walking ability at discharge categorized by ambulatory, wheelchair (outdoor only), wheelchair (outdoor and indoor), bedridden

    Time frame: 1-year

  4. any severe ventricular arrhythmic event during hospitalization

    Time frame: 1-year

  5. onset of atrial fibrillation events during hospitalization

    Time frame: 1-year

  6. any bradyarrhythmic event during hospitalization

    Time frame: 1-year

  7. any stroke during hospitalization

    Time frame: 1-year

  8. any cardiac surgery during hospitalization

    Time frame: 1-year

  9. any cateter intervention during hospitalization

    Time frame: 1-year

  10. any device implantation during hospitalization

    Time frame: 1-year

  11. bleeding events during hospitalization (GUSTO definition; moderate to severe)

    Time frame: 1-year

  12. adverse drug events during hospitalization

    Time frame: 1-year

  13. infectious diseases during hospitalization

    Time frame: 1-year

  14. change of BNP at discharge (≧30% compared to BNP at admission )

    Time frame: 1-year

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

    Time frame: 1-year

  16. usage of guideline recommended medicine during hospitalization

    Time frame: 1-year

  17. usage of tolvaptan during hospitalization

    Time frame: 1-year

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Registry information

Acronym: KCHF

Important dates

Study start
2014
Primary completion
2019
Study completion
2021
First posted
Jan 8, 2015
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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