UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018966 |
|---|---|
| Receipt number | R000021944 |
| Scientific Title | LOw-Dose Tolvaptan in Decompensated Heart Failure Patients with Severe Aortic Stenosis - LOHAS registry - |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2021/09/15 13:43:34 |
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Basic information
Public title
LOw-Dose Tolvaptan in Decompensated Heart Failure Patients with Severe Aortic Stenosis
- LOHAS registry -
Acronym
LOHAS registry
Scientific Title
LOw-Dose Tolvaptan in Decompensated Heart Failure Patients with Severe Aortic Stenosis
- LOHAS registry -
Scientific Title:Acronym
LOHAS registry
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safeness and efficacy of tolvaptan in decompensated CHF patients with severe aortic stenosis (AS).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Change of body weight between admission and day 4
2. Daily and 4-days total of Urine volume and Fluid balance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(i) HF patients with severe AS who have already received standard therapy of HF.
(ii) Registration is performed immediately after informed consent is obtained (within 24 hours after the admission) by on-site physician.
(iii) 7.5 mg of tolvaptan starts on day 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Acutely decompensated HF patients (symptomatic) with severe AS (AVA<1.0 cm2)
* Patients are diagnosed as CHF under Framingham heart failure diagnostic criteria.
Key exclusion criteria
1. Patients presenting shock vital as <90 mmHg of systolic BP on admission
2. Patients suffering acute coronary syndrome within 30 days prior to admission
3. Patients with active systemic infection
4. Patients with hypernatremia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Watanabe |
Organization
Teikyo university school of medicine
Division name
Cardiology
Zip code
1738606
Address
2-11-1 kaga itabashi-ku Tokyo Japan
TEL
03-3964-1211
yusuke0831@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Watanabe |
Organization
Teikyo university school of medicine
Division name
Cardiology
Zip code
1738606
Address
2-11-1 kaga itabashi-ku Tokyo Japan
TEL
03-3964-1211
Homepage URL
yusuke0831@gmail.com
Sponsor or person
Institute
Japan Cardiocore
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical
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
Ethics Committee of Teikyo University of Medicine
Address
2-11-1 Kaga, Itabashi
Tel
03-3964-7256
turb-office@teikyo-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
| 2016 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
http://sunrise-lab.net/wp/wp-content/uploads/2016/07/LOHAS_%E7%A0%94%E7%A9%B6%E6%A6%82%E8%A6%81%E3%8
Publication of results
Published
Result
URL related to results and publications
https://www.internationaljournalofcardiology.com/article/S0167-5273(19)34524-3/fulltext
Number of participants that the trial has enrolled
59
Results
Body weight continuously decreased, and fluid balance was maintained from baseline to day 4 (p < 0.001, p = 0.194, respectively). Median serum B-type natriuretic peptide concentration significantly decreased from 910.5 to 740.0 pg/mL by day 4 (p = 0.002). However, systolic blood pressure and heart rate were non-significantly changed (p = 0.250, p = 0.656, respectively). Hypernatremia (>150 mEq/L) and worsening renal function occurred in 2 (3.4%) and 4 (6.8%) patients, respectively.
Results date posted
| 2020 | Year | 09 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Tolvaptan exerts potent diuretic effects in heart failure patients without hemodynamic instability. Nonetheless, its clinical efficacy for acute decompensated heart failure (ADHF) due to severe aortic stenosis (AS) remains unclear. This study aimed to evaluate the short-term effects of tolvaptan in ADHF patients with severe AS.
Participant flow
The LOw-Dose Tolvaptan (7.5 mg) in Decompensated Heart Failure Patients with Severe Aortic Stenosis (LOHAS) registry is a multicenter (7 centers) prospective registry that assessed the short-term effects of tolvaptan in subjects hospitalized for ADHF with severe AS. A total of 59 subjects were enrolled between September 2014 and December 2017. The primary endpoints were changes in body weight and fluid balance measured daily from baseline up to 4 days.
Adverse events
Hypernatremia (>150 mEq/L) and worsening renal function occurred in 2 (3.4%) and 4 (6.8%) patients, respectively.
Outcome measures
Body weight continuously decreased, and fluid balance was maintained from baseline to day 4 (p < 0.001, p = 0.194, respectively). Median serum B-type natriuretic peptide concentration significantly decreased from 910.5 to 740.0 pg/mL by day 4 (p = 0.002). However, systolic blood pressure and heart rate were non-significantly changed (p = 0.250, p = 0.656, respectively).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 10 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021944
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