UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051288 |
|---|---|
| Receipt number | R000058496 |
| Scientific Title | Low versus Moderate Sodium Diet in Hospitalized Patients with Acute Decompensated Heart Failure |
| Date of disclosure of the study information | 2023/06/10 |
| Last modified on | 2023/07/03 18:59:37 |
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Basic information
Public title
Low versus Moderate Sodium Diet in Hospitalized Patients with Acute Decompensated Heart Failure
Acronym
SODIUM ADHF Pilot Study
Scientific Title
Low versus Moderate Sodium Diet in Hospitalized Patients with Acute Decompensated Heart Failure
Scientific Title:Acronym
SODIUM ADHF Pilot Study
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to determine whether providing a sodium low-restricted diet equivalent to 8 g of salt per day compared to a sodium restricted diet equivalent to 6 g of salt per day improves total energy intake and total energy intake sufficiency for 7 days after intervention for 65 years and older patients with heart failure in hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are average total daily energy intake and average total energy intake sufficiency rate from the start of the intervention diet to the time of discharge if the patient is discharged within 7 days of the start of the intervention diet and within 7 days of the start of the intervention diet.
Key secondary outcomes
1. Average daily salt intake during the first 7 days of intervention
2. Average daily nutrient sufficiency rate during the first 7 days of intervention
3. Serum sodium values after 7 days intervention
4. Urinary sodium values after 7 days intervention
5. Change in CFS level before hospitalization and on day 7 of the intervention
6. Changes in BNP values on day 7 from the start of the intervention
7. Change in PNI level on day 7 from the start of the intervention
8. Change in JSNAQ value on day 7 from the start of the intervention
9. Change in grip strength on day 7 from the start of the intervention
10. Events occurring up to 60 days of intervention (cardiac death, heart failure death, cardiovascular death, sudden cardiac death, non-cardiac death, all cause death, heart failure exacerbation, heart failure hospitalization, cardiovascular hospitalization, non-cardiac hospitalization, infections, falls, emergency visits, low serum sodium, low Hb)
11. Average daily total energy intake from discharge to first nutrition counseling
12. Estimated daily salt intake from discharge to first nutrition counseling
13. Average daily nutrient sufficiency rate from discharge to first nutrition counseling
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mildly sodium restricted diet equivalent to 8 g of salt per day for 7 days
Interventions/Control_2
Sodium restricted diet equivalent to 6 g of salt per day for 7 days
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. Patient is hospitalized with a diagnosis of heart failure that meets Framingham criteria.
2. Patient is receiving appropriate treatment according to the guidelines and is hemodynamically stable.
3. Patient is 65 years old or older
4. Patient is able to take oral diet
5. Patients with systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg
6. Patients with a Barthel Index of 85 or higher
7. Written consent for participation in the study has been obtained from the patients themselves
Key exclusion criteria
1. Heart failure patients who required endotracheal intubation or treatment with an assistive circulatory device after hospitalization
2. End-stage renal failure eGFR<15mL/min/1.73m2
3. Serum Na<130 mmol/L
4. Patients who require restrictions other than salt and energy intake as a therapeutic diet
5. Patients with dysgeusia and receiving treatment for dysgeusia
6. Patients with malignant tumors under treatment
7. Patients who are under palliative care or whose prognosis for life is estimated to be less than one year
8. Patients who have difficulty understanding the treatment or research
9. Patients with a history of heart transplantation, or patients who have or are scheduled to receive an artificial heart.
10. In addition to the above, patients who are deemed inappropriate for the study by the principal investigator, research coordinator, or collaborating physicians.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University Hospital
Division name
Department of Cardiology
Zip code
606-8507
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4255
nei126@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University Hospital
Division name
Department Cardiology
Zip code
606-8507
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4255
Homepage URL
nei126@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Koichi Washida
Funding Source
Organization
undecided
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
54 Shogoin Kawahara-cho, Sakyo-ku
Tel
075-751-4899
trans@kuhp.kyoto-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 10 | 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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058496
