UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013819 |
|---|---|
| Receipt number | R000016129 |
| Scientific Title | Effect of Low-Dose Carperitide in Patients With Acute Decompensated Heart Failure The Randomized Trial (Low-dose AdminiStration of CARperitide for Acute Heart Failure:LASCAR-AHF study) |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2024/04/05 21:51:10 |
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Basic information
Public title
Effect of Low-Dose Carperitide in Patients With Acute Decompensated Heart Failure
The Randomized Trial
(Low-dose AdminiStration of CARperitide for Acute Heart Failure:LASCAR-AHF study)
Acronym
Low-Dose Carperitide on Acute Decompensated Heart Failure
Scientific Title
Effect of Low-Dose Carperitide in Patients With Acute Decompensated Heart Failure
The Randomized Trial
(Low-dose AdminiStration of CARperitide for Acute Heart Failure:LASCAR-AHF study)
Scientific Title:Acronym
Low-Dose Carperitide on Acute Decompensated Heart Failure
Region
| Japan |
Condition
Condition
Acute Decompensated Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The LASCAR-AHF was designed to investigate benefits of low dose carperitide on mortality or HF hospitalization in addition to standard treatment in a randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite of all-cause death and HF hospitalization
events of HF hospitalizations must have clinical manifestations of worsening HF (new or worsening dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiological evidence of worsening HF) and additional/increased therapy, specifically for the treatment of worsening HF with at least one of the following:
1. Intravenous treatment with a diuretic, inotropic, vasodilator, or other recognized intravenous HF treatment
2. Mechanical or surgical intervention (mechanical circulatory support) or the use of ultrafiltration, hemofiltration, or dialysis specifically directed at treatment of HF
Key secondary outcomes
Decongestion
Cumulative urinary volume at 72 h
Urinary sodium excretion at 72 h
Change in body weight from randomization to 72 h
Symptom relief
Change in degree of dyspnea assessed by area under the curve of visual
analogue scale over 72 h
Renal function
Change in eGFR from randomization to 72 h
Serum cystatin-C level from randomization to 72 h
Biomarkers
Change in plasma brain natriuretic peptide, renin, aldosterone, dopamine, adrenaline and noradrenaline levels, and serum sodium, potassium, chloride and neutrophil gelatinase-associated lipocalin levels from randomization to 72 h
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control (without HANP)
1. Frosemide 40mg/day 24hours after randomization
2. Twice frosemide dose of 7 days before admission.
3. Dietary restriction (Sodium: 6000mg/day, Water: 1500mL/day)
4. Treatment after 72hours following randomization will be depend on the each physician
Interventions/Control_2
Intervention (with HANP)
1. Low dose carperitide with protocol of control group
2. Carperitide 0.02 ug per kg per min 72 hours after randomization (permission to adjust 0.01 through 0.02ug per kg per min, depend on each physician)
3. Carperitide should be stopped in case of sustained hypotention (systolic blood pressure below 90 mmHg)
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diagnosis of Acute HF
At least 1 symptom (dyspnea, orthopnea, or edema)
At least 1 sign (rales, edema, ascites, chest radiographic signs of HF)
Enrolled within 6 hours of hospital admission
Age above 20, below 85 years
Systolic BP 100 mmHg and above
Willingness to provide written informed consent
Key exclusion criteria
No indication of intravenous vasodilators or diuretics for initial treatments
Carperitide administration before randomization
Receiving dialysis
eGFR less than 15 mL/min/1.73m2
Acute coronary syndrome
Possible for pregnancy
Enrolled other clinical trials
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Honda |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
5648565
Address
6-1 kishibeshinmachi, Suita, Osaka
TEL
0570-012-545
satoshi.honda@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Hokkaido University
Division name
Cardiovascular Medicine
Zip code
0608638
Address
Kita 15 Nishi 7 Kita-ku Sapporo
TEL
011-706-6973
Homepage URL
nagai@med.hokudai.ac.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular
Center, Division of Cardiovascular
Medicine
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular
Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Research Foundation for Clinical Pharmacology
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
5-7-1 fujishirodai, Suita, Osaka
Tel
06-6833-5012
nagai@ncvc.go.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
国立循環器病研究センター病院 心臓血管内科部門（大阪府）
東京医大八王子医療センター循環器内科（東京都）
神戸医療センター中央市民病院循環器内科（兵庫県）
聖路加国際病院循環器内科（東京都）
沖縄県立中部病院循環器内科（沖縄県）
国立病院機構栃木医療センター循環器内科（栃木県）
北海道大学医学研究院 循環病態内科学（北海道）
市立函館病院 循環器科（北海道）
市立釧路総合病院 心臓血管内科（北海道）
東京医科大学病院 循環器内科（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016129
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