Congestive Heart FailureKCHFNCT02334891
Kyoto Congestive Heart Failure Study
An observational study of Congestive Heart Failure and Heart Failure, Diastolic, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congestive Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic
- What is being tested?
- Standard
- How many people
- 4,056 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to 30 Mar 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham criteria
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiovascular Medicine, Kyoto University Hospital
Kyoto, 606-8507
About this 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.
Read the 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.
- Conditions
- Congestive Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic, Elderly Frail, Guideline Adherence
- Being tested
- Standard
- Keywords
- congestive heart failure, heart failure, diastolic, heart failure, systolic, elderly frail, guideline adherence
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardOther
Standard management
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital mortality
Measured: 1-year
Secondary outcomes (17)
functional level at discharge measured by NYHA classification
Measured: 1-year
improvement of dyspnea level at discharge measured by Likert scale
Measured: 1-year
walking ability at discharge categorized by ambulatory, wheelchair (outdoor only), wheelchair (outdoor and indoor), bedridden
Measured: 1-year
any severe ventricular arrhythmic event during hospitalization
Measured: 1-year
onset of atrial fibrillation events during hospitalization
Measured: 1-year
any bradyarrhythmic event during hospitalization
Measured: 1-year
any stroke during hospitalization
Measured: 1-year
any cardiac surgery during hospitalization
Measured: 1-year
any cateter intervention during hospitalization
Measured: 1-year
any device implantation during hospitalization
Measured: 1-year
bleeding events during hospitalization (GUSTO definition; moderate to severe)
Measured: 1-year
adverse drug events during hospitalization
Measured: 1-year
infectious diseases during hospitalization
Measured: 1-year
change of BNP at discharge (≧30% compared to BNP at admission )
Measured: 1-year
worsening renal function at discharge (raise of Cr≧0.3mg/dl compared to Cr at admission )
Measured: 1-year
usage of guideline recommended medicine during hospitalization
Measured: 1-year
usage of tolvaptan during hospitalization
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2019
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,056 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takeshi Morimoto, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, MD, PhD, Principal investigator, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School and Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334891
- Sponsor's protocol ID
- E2311
- Acronym
- KCHF
- Status last verified
- Sep 2021
- First submitted
- 28 Dec 2014
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Nishikawa R, Kato T, Morimoto T, Yaku H, Inuzuka Y, Tamaki Y, Yamamoto E, Ozasa N, Tada T, Sakamoto H, Seko Y, Shiba M, Yoshikawa Y, Yamashita Y, Kitai T, Taniguchi R, Iguchi M, Nagao K, Kawai T, Komasa A, Kawase Y, Morinaga T, Toyofuku M, Furukawa Y, Ando K, Kadota K, Sato Y, Kuwahara K, Kimura T; KCHF Study Investigators. The characteristics and outcomes in patients with acute heart failure who used tolvaptan: from KCHF registry. ESC Heart Fail. 2023 Oct;10(5):3141-3151. doi: 10.1002/ehf2.14494. Epub 2023 Aug 29.
PubMed 37644779Aida K, Nagao K, Kato T, Yaku H, Morimoto T, Inuzuka Y, Tamaki Y, Yamamoto E, Yoshikawa Y, Kitai T, Taniguchi R, Iguchi M, Kato M, Takahashi M, Jinnai T, Kawai T, Komasa A, Nishikawa R, Kawase Y, Morinaga T, Su K, Kawato M, Seko Y, Inada T, Inoko M, Toyofuku M, Furukawa Y, Nakagawa Y, Ando K, Kadota K, Shizuta S, Ono K, Sato Y, Kuwahara K, Ozasa N, Kimura T. Prognostic Value of the Severity of Clinical Congestion in Patients Hospitalized for Decompensated Heart Failure: Findings From the Japanese KCHF Registry. J Card Fail. 2023 Aug;29(8):1150-1162. doi: 10.1016/j.cardfail.2023.01.003. Epub 2023 Jan 21.
PubMed 36690136Nishimoto 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.
PubMed 35289117Seko 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.
PubMed 34730004Washida 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.
PubMed 34325523Nishimoto 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.
PubMed 33376169Yaku 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.
PubMed 32066601
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kyoto Congestive Heart Failure Study
- ClinicalTrials.gov ID
- NCT02334891
- Acronym / sponsor ID
- KCHF / E2311
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,056 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham criteria
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StandardStandard management | Other | – |
Primary outcome
hospital mortality
Time frame: 1-year
17 secondary outcomes
functional level at discharge measured by NYHA classification
Time frame: 1-year
improvement of dyspnea level at discharge measured by Likert scale
Time frame: 1-year
walking ability at discharge categorized by ambulatory, wheelchair (outdoor only), wheelchair (outdoor and indoor), bedridden
Time frame: 1-year
any severe ventricular arrhythmic event during hospitalization
Time frame: 1-year
onset of atrial fibrillation events during hospitalization
Time frame: 1-year
any bradyarrhythmic event during hospitalization
Time frame: 1-year
any stroke during hospitalization
Time frame: 1-year
any cardiac surgery during hospitalization
Time frame: 1-year
any cateter intervention during hospitalization
Time frame: 1-year
any device implantation during hospitalization
Time frame: 1-year
bleeding events during hospitalization (GUSTO definition; moderate to severe)
Time frame: 1-year
adverse drug events during hospitalization
Time frame: 1-year
infectious diseases during hospitalization
Time frame: 1-year
change of BNP at discharge (≧30% compared to BNP at admission )
Time frame: 1-year
worsening renal function at discharge (raise of Cr≧0.3mg/dl compared to Cr at admission )
Time frame: 1-year
usage of guideline recommended medicine during hospitalization
Time frame: 1-year
usage of tolvaptan during hospitalization
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Derived from this study: PubMed 37644779Nishikawa R, Kato T, Morimoto T, Yaku H, Inuzuka Y, Tamaki Y, Yamamoto E, Ozasa N, Tada T, Sakamoto H, Seko Y, Shiba M, Yoshikawa Y, Yamashita Y, Kitai T, Taniguchi R, Iguchi M, Nagao K, Kawai T, Komasa A, Kawase Y, Morinaga T, Toyofuku M, Furukawa Y, Ando K, Kadota K, Sato Y, Kuwahara K, Kimura T; KCHF Study Investigators. The characteristics and outcomes in patients with acute heart failure who used tolvaptan: from KCHF registry. ESC Heart Fail. 2023 Oct;10(5):3141-3151. doi: 10.1002/ehf2.14494. Epub 2023 Aug 29.
- Derived from this study: PubMed 36690136Aida K, Nagao K, Kato T, Yaku H, Morimoto T, Inuzuka Y, Tamaki Y, Yamamoto E, Yoshikawa Y, Kitai T, Taniguchi R, Iguchi M, Kato M, Takahashi M, Jinnai T, Kawai T, Komasa A, Nishikawa R, Kawase Y, Morinaga T, Su K, Kawato M, Seko Y, Inada T, Inoko M, Toyofuku M, Furukawa Y, Nakagawa Y, Ando K, Kadota K, Shizuta S, Ono K, Sato Y, Kuwahara K, Ozasa N, Kimura T. Prognostic Value of the Severity of Clinical Congestion in Patients Hospitalized for Decompensated Heart Failure: Findings From the Japanese KCHF Registry. J Card Fail. 2023 Aug;29(8):1150-1162. doi: 10.1016/j.cardfail.2023.01.003. Epub 2023 Jan 21.
- Derived from this study: PubMed 35289117Nishimoto 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.
- Derived from this study: PubMed 34730004Seko 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.
- Derived from this study: PubMed 34325523Washida 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.
- Derived from this study: PubMed 33376169Nishimoto 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.
- Derived from this study: PubMed 32066601Yaku 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Kimura, MD, PhD principal investigator
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School and Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Heart Failure, Diastolic, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital mortality (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02334891, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.