UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061438 |
|---|---|
| Receipt number | R000070214 |
| Scientific Title | In-hospital trajectory of muscle mass changes assessed with repeated ultrasonography in older patients with acute heart failure: A single-center prospective cohort study |
| Date of disclosure of the study information | 2026/05/02 |
| Last modified on | 2026/05/01 20:40:11 |
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Basic information
Public title
In-hospital trajectory of muscle mass changes assessed with repeated ultrasonography in older patients with acute heart failure:
A single-center prospective cohort study
Acronym
ATTENTION-HF
Scientific Title
In-hospital trajectory of muscle mass changes assessed with repeated ultrasonography in older patients with acute heart failure:
A single-center prospective cohort study
Scientific Title:Acronym
ATTENTION-HF
Region
| Japan |
Condition
Condition
Acute Heart Failure
Classification by specialty
| Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Low muscle mass is a poor prognostic factor in patients with heart failure, but no studies have captured changes in muscle mass. The purpose of this study is to clarify the temporal changes in lower limb muscle mass during hospitalization in patients aged 65 years or older who were hospitalized with acute heart failure, based on skeletal muscle ultrasound examinations at multiple time points.
Basic objectives2
Others
Basic objectives -Others
Exploratory cohort study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage change in quadriceps femoris muscle thicknesss as evaluated by skeletal muscle ultrasound on day 1 and on days 3, 5, 7, and 10.
Key secondary outcomes
Percentage change in rectus femoris muscle thickness, triceps surae muscle thickness, biceps brachii muscle thickness, triceps brachii muscle thickness, forearm muscle thickness, and diaphragm muscle thickness as evaluated by skeletal muscle ultrasound on day 1 and on days 3, 5, 7, and 10.
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
1) The patients who were admitted to hospital due to acute heart failure
2) The diagnosis of heart failure is based on the Framingham criteria
3) The patients older than 65 years old
4) The patients who can walk by themselves before admission (including the patients who can walk using a staff and so on)
Key exclusion criteria
1) The patients discharged within 9 days
2) The patients with NT-proBNP < 300 pg/mL at admission
3) The patients with acute coronary syndrome
4) The patients with acute myocarditis, acute pericarditis, or acute infective endocarditis
5) The patients undergoing maintenance dialysis
6) The patients undergoing continuous hemodiafiltration
7) The patients with symptomatic aortic stenosis, mitral stenosis, or obstructive hypertrophic cardiomyopathy
8) The patients receiving high-dose intravenous inotropic agents
9) The patients with untreated life-threatening arrhythmias
10) The patients with circulatory support
11) The patients using invasive mechanical ventilation
12) The patients who died in the hospital
13) The patients who did not provide consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Matsuo |
Organization
Sagamihara Kyodo Hospital
Division name
Department of Rehabilitation
Zip code
252-5188
Address
4-3-1 Hashimotodai, Midori Ward, Sagamihara City, Kanagawa-ken
TEL
042-761-6020
kouji.matsuo.0123@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Matsuo |
Organization
Sagamihara Kyodo Hospital
Division name
Department of Rehabilitation
Zip code
252-5188
Address
4-3-1 Hashimotodai, Midori Ward, Sagamihara City, Kanagawa-ken
TEL
042-761-6020
Homepage URL
kouji.matsuo.0123@gmail.com
Sponsor or person
Institute
Sagamihara Kyodo Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Ethics Committee of the Sagamihara Kyodo Hospital
Address
4-3-1 Hashimotodai, Midori Ward, Sagamihara City, Kanagawa-ken
Tel
042-761-6020
koseiren-kenshu@bunkaren.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
相模原協同病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Design
Single-center prospective cohort study
Patient selection
Patients who met the inclusion criteria and do not conflict with the exclusion criteria. (These criteria are stated above)
Observation
Patient information, laboratory tests, and physical findings obtained during routine clinical care, as well as the following skeletal muscle ultrasound measurements: quadriceps femoris thickness, rectus femoris thickness, triceps surae thickness, biceps brachii thickness, triceps brachii thickness, forearm muscle thickness, and diaphragm thickness; for body circumference measurements, we measure thigh circumference, lower leg circumference, upper arm circumference, forearm circumference, waist circumference, and hip circumference; for patients who are able, we measure skeletal muscle mass in the limbs using bioelectrical impedance analysis. Additionally, as indicators of physical function and physical activity, grip strength, walking speed, the 5-repetition sit-to-stand test, the Short Physical Performance Battery, step count, and the Barthel Index will be measured. Furthermore, as indicators of nutritional status, we will assess the Global Leadership Initiative on Malnutrition criteria, the Mini Nutritional Assessment-Short Form, and caloric intake; for swallowing function, the Food Intake LEVEL scale; for frailty, the Fried criteria and Frailty Score; and for cachexia, annual weight change, appetite, fatigue, muscle strength, lean body mass, and blood biochemical markers.
Management information
Registered date
| 2026 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070214
