UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053725 |
|---|---|
| Receipt number | R000061309 |
| Scientific Title | Impact of accelerated titration of guideline directed medical therapy on reverse remodeling for acute heart failure |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/05/24 13:55:19 |
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Basic information
Public title
Impact of accelerated titration of guideline directed medical therapy on reverse remodeling for acute heart failure
Acronym
MANUAL study
Scientific Title
Impact of accelerated titration of guideline directed medical therapy on reverse remodeling for acute heart failure
Scientific Title:Acronym
MANUAL study
Region
| Japan |
Condition
Condition
HFrEF
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In heart failure patients with reduced left ventricular ejection fraction, four drugs have been shown to improve prognosis: 1) ACE inhibitors or angiotensin receptor neprilysin inhibitors (ARNi) 2) beta-blockers 3) mineralocorticoid receptor antagonists (MRAs) 4) SGLT2 inhibitors. They are referred to as standard guideline-recommended agents. The latest heart failure guidelines in Japan describe the following dosing sequence: 1. ACE inhibitor or ARNi, 2. beta-blocker, 3. MRA, 4. SGLT2 inhibitor. At present, however, the order in which they should be administered is left to the discretion of the physician.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of LVEF during 3 months
Key secondary outcomes
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
Usual care group prescribes ACE-I ARB or ARNi be-ta-blocker MRA and SGLT2 inhibitor in that order.
Interventions/Control_2
The Accelerated care group prescribes SGLT2 inhibitors, MRAs, ACE-I ARBs or ARNi and beta blockers in that order.
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
ADHF with LVEF less than 50%
eGFR more than 30 mL/min/m2
Key exclusion criteria
Cardiogenic shockPatients taking two or more GDMT
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
1179-3, Nagasone-cho, kita-ku, Sakai city
TEL
072-252-3561
mnishino@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Shodai |
| Middle name | |
| Last name | Kawanami |
Organization
Osaka Rosai Hospital
Division name
Cardiology
Zip code
591-8025
Address
1179-3, Nagasone-cho, kita-ku, Sakai city
TEL
072-252-3561
Homepage URL
mnishino@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
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
1179-3, Nagasone-cho, kita-ku, Sakai city
Tel
072-252-3561
mnishino@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
| 2024 | Year | 03 | Month | 01 | 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
| 2024 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061309
