UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031635 |
|---|---|
| Receipt number | R000035365 |
| Scientific Title | Comparison of various methods in evaluation of sarcopenia in patients with heart failure: A multicenter prospective observational study |
| Date of disclosure of the study information | 2018/03/08 |
| Last modified on | 2025/01/30 09:41:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of various methods in evaluation of sarcopenia in patients with heart failure: A multicenter prospective observational study
Acronym
Comparison of various methods in evaluation of sarcopenia in patients with heart failure (SONIC-HF)
Scientific Title
Comparison of various methods in evaluation of sarcopenia in patients with heart failure: A multicenter prospective observational study
Scientific Title:Acronym
Comparison of various methods in evaluation of sarcopenia in patients with heart failure (SONIC-HF)
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the difference in prognostic impact of measuring muscle mass and function using ultrasound as well as anthropometric measurements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause mortality
Key secondary outcomes
Unexpected visit to the hospital, readmission due to heart failure, all-cause readmission.
Physical and functional status at baseline.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who were admitted to each hospital due to heart failure
(1) The diagnosis of heart failure is based on the Framingham criteria, which is stated in the guideline of Japanese Circulation Society (http://www.j-circ.or.jp/guideline/pdf/JCS2011_izumi_h.pdf ; last accessed August 7th, 2016).
(2) The patients older than 64 years old are eligible
(3) The patients who can walk by themselves (including the patients who can walk using a staff and so on) are eligible (who suffered in-hospital death will be excluded)
Key exclusion criteria
(1) The patients with low serum BNP (<100pg/ml) / NT-pro BNP (<300pg/ml) level on admission
(2) The hemodialysis patients (including the patients planning to start hemodialysis)
(3) The patients planning to undergo surgery for valvular heart disease or similar surgery
(4) The patients who had undergone heart transplantation or the patients with ventricular assist devices
(5) The patients with acute myocarditis
(6) The patients who refused to participate in the study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Emi / Nobuyuki |
| Middle name | |
| Last name | Maekawa / Kagiyama |
Organization
Kitasato University School of Medicine / Juntendo University
Division name
Department of Cardiovascular Medicine / Department of Cardiovascular Biology and Medicine
Zip code
252-0373
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
emimae1207@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Maekawa |
Organization
Kitasato University School of Medicine / Juntendo University
Division name
Department of Cardiovascular Medicine / Department of Cardiovascular Medicine
Zip code
252-0373
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
emimae1207@med.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Novartis Foundation (Japan)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1 Chome-15-1 Kitazato, Minami Ward, Sagamihara, Kanagawa 252-0374
Tel
042-778-8111
rinri@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
B17-210
Org. issuing International ID_1
Kitasato University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北里大学病院、心臓病センター榊原病院、亀田総合病院、神戸市立医療センター中央市民病院、順天堂大学病院、東部地域病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.medrxiv.org/content/10.1101/2024.10.16.24315221v1
Publication of results
Published
Result
URL related to results and publications
https://www.jacc.org/doi/10.1016/j.jcmg.2024.09.012
Number of participants that the trial has enrolled
700
Results
A total of 692 patients were enrolled, with 606 undergoing ultrasound. Median muscle thicknesses were 19.6 mm for the biceps brachii, 19.0 mm for the quadriceps, and 1.9 mm for the diaphragm. Notably, quadriceps and diaphragmatic thicknesses were significantly associated with heart failure-related hospitalizations and mortality.
Results date posted
| 2025 | Year | 01 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 18 | Day |
Baseline Characteristics
A total of 692 patients were enrolled, with 606 undergoing ultrasound. The median age was 81 years, and 42.4% were male. Advanced heart failure (NYHA class III+) was present in 19.9%. The median left ventricular ejection fraction was 45%, with approximately 42% classified as HFpEF and 42% as HFrEF.
Participant flow
Of 692 patients enrolled, 606 underwent ultrasound.
Adverse events
No adverse events reported due to the observational nature of the study
Outcome measures
Median muscle thicknesses were 19.6 mm for the biceps brachii, 19.0 mm for the quadriceps, and 1.9 mm for the diaphragm. Notably, quadriceps and diaphragmatic thicknesses were significantly associated with heart failure-related hospitalizations and mortality.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multi-center registry study will include geriatric patients with heart failure. In addition to the patient characteristics and results of clinically indicated tests, the following tests will be performed: The assessment of muscle mass and function using ultrasound, physical function tests, etc. Frailty factors will be also evaluated as important confounders. Predictors for all-cause death will be investigated.
Management information
Registered date
| 2018 | Year | 03 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035365
