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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043656
Receipt No. R000049856
Scientific Title Decongestion in patients with heart failure by sacubitrill-valsartan
Date of disclosure of the study information 2021/03/18
Last modified on 2021/03/18

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Basic information
Public title Decongestion in patients with heart failure by sacubitrill-valsartan
Acronym DRY-START trial
Scientific Title Decongestion in patients with heart failure by sacubitrill-valsartan
Scientific Title:Acronym DRY-START trial
Region
Japan

Condition
Condition heart failure with congestion
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of sacubitrill-valsartan for the patients with heart failure with preserved ejection fraction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improvement of congestion evaluated by transthoracic echocardiography at 6 month
Key secondary outcomes The improvement of congestion evaluated by transthoracic echocardiography at 12 month

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sacvitrill-valsartan
12 month
maximum dose if tolerant
Interventions/Control_2 enarapril or valsartan
12 month
maximum dose if tolerant
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
100 years-old >
Gender Male and Female
Key inclusion criteria The patients who have acute decompensated heart failure with NT-pro BNP more than 200pg/ml(sinus), 600pg/ml(AF).
The transthoracic echocardiography shows congestion and EF>40% at discharge.
Key exclusion criteria EF<40% or TTE does not show congestion
severe valvular disease
congenital heart disease
constrictive pericarditis
systolic blood pressure<110mmHg
eGFR<30ml/min/1.73m2
K>5.2mmol/L
Patients who does not take ACE-I/ARB or who can not take them.
life expectancy < 6 months due to non-cardiovascular diseases
Target sample size 100

Research contact person
Name of lead principal investigator
1st name masami
Middle name
Last name nishino
Organization Osaka Rosai Hospital
Division name cardiology
Zip code 591-8025
Address 3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL 072-252-3561
Email mnishino@osakah.johas.go.jp

Public contact
Name of contact person
1st name yutaka
Middle name
Last name matsuhiro
Organization osaka rosai hospital
Division name cardiology
Zip code 591-8025
Address 3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL 072-252-3561
Homepage URL
Email junnai-hisho@osakah.johas.go.jp

Sponsor
Institute osaka rosai hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization osaka rosai hospital
Address 3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
Tel 072-252-3561
Email junnai-hisho@osakah.johas.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

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 18 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 Open public recruiting
Date of protocol fixation
2021 Year 03 Month 01 Day
Date of IRB
2021 Year 03 Month 14 Day
Anticipated trial start date
2021 Year 03 Month 18 Day
Last follow-up date
2026 Year 03 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 18 Day
Last modified on
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049856

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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