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Kyoto Congestive Heart Failure Study (KCHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02334891
Recruitment Status : Active, not recruiting
First Posted : January 8, 2015
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

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
Congestive Heart Failure Heart Failure, Diastolic Heart Failure, Systolic Elderly Frail Guideline Adherence 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 4056 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Kyoto Congestive Heart Failure Study
Actual Study Start Date : October 2014
Actual Primary Completion Date : March 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Other: Standard
    Standard management


Primary Outcome Measures :
  1. hospital mortality [ Time Frame: 1-year ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334891


Locations
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Japan
Department of Cardiovascular Medicine, Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Investigators
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Principal Investigator: Takeshi Kimura, MD, PhD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School and Faculty of Medicine
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT02334891    
Other Study ID Numbers: E2311
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:
congestive heart failure
heart failure, diastolic
heart failure, systolic
elderly frail
guideline adherence
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases