Clinical trial NCT02334891: Kyoto Congestive Heart Failure Study
Official title: Kyoto Congestive Heart Failure Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Heart Failure, Diastolic
Heart Failure, Systolic
Elderly Frail
Guideline Adherence
Keywords: congestive heart failure
heart failure, diastolic
heart failure, systolic
elderly frail
guideline adherence
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 4056
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: hospital mortality
timeFrame: 1-year
Secondary outcomes:
measure: functional level at discharge measured by NYHA classification
timeFrame: 1-year
measure: improvement of dyspnea level at discharge measured by Likert scale
timeFrame: 1-year
measure: walking ability at discharge categorized by ambulatory, wheelchair (outdoor only), wheelchair (outdoor and indoor), bedridden
timeFrame: 1-year
measure: any severe ventricular arrhythmic event during hospitalization
timeFrame: 1-year
measure: onset of atrial fibrillation events during hospitalization
timeFrame: 1-year
measure: any bradyarrhythmic event during hospitalization
timeFrame: 1-year
measure: any stroke during hospitalization
timeFrame: 1-year
measure: any cardiac surgery during hospitalization
timeFrame: 1-year
measure: any cateter intervention during hospitalization
timeFrame: 1-year
measure: any device implantation during hospitalization
timeFrame: 1-year
measure: bleeding events during hospitalization (GUSTO definition; moderate to severe)
timeFrame: 1-year
measure: adverse drug events during hospitalization
timeFrame: 1-year
measure: infectious diseases during hospitalization
timeFrame: 1-year
measure: change of BNP at discharge (≧30% compared to BNP at admission )
timeFrame: 1-year
measure: worsening renal function at discharge (raise of Cr≧0.3mg/dl compared to Cr at admission )
timeFrame: 1-year
measure: usage of guideline recommended medicine during hospitalization
timeFrame: 1-year
measure: usage of tolvaptan during hospitalization
timeFrame: 1-year
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Department of Cardiovascular Medicine, Kyoto University Hospital
Study officials:
affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School and Faculty of Medicine
name: Takeshi Kimura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.