UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049926 |
|---|---|
| Receipt number | R000056866 |
| Scientific Title | Compression stockings reduce brain natriuretic peptide in patients with chronic heart failure |
| Date of disclosure of the study information | 2023/01/05 |
| Last modified on | 2024/06/28 09:34:27 |
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Basic information
Public title
Compression stockings reduce brain natriuretic peptide in patients with chronic heart failure
Acronym
Compression stockings reduce brain natriuretic peptide in patients with chronic heart failure
Scientific Title
Compression stockings reduce brain natriuretic peptide in patients with chronic heart failure
Scientific Title:Acronym
Compression stockings reduce brain natriuretic peptide in patients with chronic heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
compression stockings' medium-term effects and safety for heart failure patients have not yet been proven. The present study aimed to elucidate the medium- and long-term effects and safety of compression stockings in patients with chronic heart failure and examine the potential.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: NYHA assessment of heart failure symptoms and heart failure hospitalisation in the outpatient clinic following elastic stocking use.
Secondary endpoints: serum BNP levels, renal function and skin complications in the outpatient clinic visits following elastic stocking use.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We retrospectively collected patients with chronic heart failure attending outpatients at three centres who wore new compression stockings between 2018 and 2021 with medical records. The enrolment criteria for this study were new compression stockings wearers who met the following three criteria;1) Previous heart failure hospitalisation or BNP >100 pg/dL, 2) No change in oral medication, including dose, in the year prior to compression stockings wearing.
Key exclusion criteria
Excluding patients on haemodialysis.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Nasu |
| Middle name | |
| Last name | Takahito |
Organization
Iwate Medical University
Division name
Division of Cardiology,
Zip code
028-3695
Address
2-1-1 Idaidori,Yahaba-cho,Shiwa-gun,Iwate, Japan
TEL
+81-019-613-7111
tnasu@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Nasu |
| Middle name | |
| Last name | Takahito |
Organization
Iwate Medical University
Division name
Division of Cardiology,
Zip code
028-3695
Address
2-1-1 Idaidori,Yahaba-cho,Shiwa-gun,Iwate, Japan
TEL
+81-019-613-7111
Homepage URL
tnasu@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate medical University
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
Iwate Medical University
Address
2-1-1 Idaidori,Yahaba-cho,Shiwa-gun,Iwate
Tel
+81-019-613-7111
tnasu@iwate-med.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 | 01 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2352906724000095?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2352906724000095?via%3Dihub
Number of participants that the trial has enrolled
121
Results
In stable heart failure, lower limb compression therapy was associated with a reduction in BNP.
Results date posted
| 2024 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 21 | Day |
Baseline Characteristics
This study initially enrolled 101 patients. Table 1 presents the baseline data for this group. The median age of the participants was 81 years, with 62.4 % being female. Atrial fibrillation complications were present in 54.5 % of the group. The median LVEF was 55 %, and HFpEF was 55.4 %. The median BNP level was 479 pg/mL (350-691). The pitting edema scale ranged from 0 to 4, accounting for 5.9 %, 49.5 %, 29.7 %, 12.9 %, and 0 % of patients, respectively. Regarding NYHA classification, 44.6 % of patients were classified as 2, and 55.4 % as 3. Loop diuretics were administered to almost all patients (98.0 %).
Participant flow
This retrospective study collected data from patients with stable chronic HF who visited our outpatient department at three centers and received compression therapy through new compression stockings from 2018 to 2021.
Adverse events
This retrospective study
Outcome measures
In this retrospective analysis of our patient data, we identified the change in NYHA class at 1 month as the primary endpoint.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
retrospectively registry
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056866
