Congestive Heart Failure Clinical Trial
— KCHFOfficial title:
Kyoto Congestive Heart Failure Study
NCT number | NCT02334891 |
Other study ID # | E2311 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | March 30, 2021 |
Verified date | September 2021 |
Source | Kyoto University, Graduate School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 4056 |
Est. completion date | March 30, 2021 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Department of Cardiovascular Medicine, Kyoto University Hospital | Kyoto |
Lead Sponsor | Collaborator |
---|---|
Kyoto University, Graduate School of Medicine |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hospital mortality | 1-year | ||
Secondary | functional level at discharge measured by NYHA classification | 1-year | ||
Secondary | improvement of dyspnea level at discharge measured by Likert scale | 1-year | ||
Secondary | walking ability at discharge categorized by ambulatory, wheelchair (outdoor only), wheelchair (outdoor and indoor), bedridden | 1-year | ||
Secondary | any severe ventricular arrhythmic event during hospitalization | 1-year | ||
Secondary | onset of atrial fibrillation events during hospitalization | 1-year | ||
Secondary | any bradyarrhythmic event during hospitalization | 1-year | ||
Secondary | any stroke during hospitalization | 1-year | ||
Secondary | any cardiac surgery during hospitalization | 1-year | ||
Secondary | any cateter intervention during hospitalization | 1-year | ||
Secondary | any device implantation during hospitalization | 1-year | ||
Secondary | bleeding events during hospitalization (GUSTO definition; moderate to severe) | 1-year | ||
Secondary | adverse drug events during hospitalization | 1-year | ||
Secondary | infectious diseases during hospitalization | 1-year | ||
Secondary | change of BNP at discharge (?30% compared to BNP at admission ) | 1-year | ||
Secondary | worsening renal function at discharge (raise of Cr?0.3mg/dl compared to Cr at admission ) | 1-year | ||
Secondary | usage of guideline recommended medicine during hospitalization | 1-year | ||
Secondary | usage of tolvaptan during hospitalization | 1-year |
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