UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056532 |
|---|---|
| Receipt number | R000064602 |
| Scientific Title | The efficacy of heart failure medications in patients with heart failure with preserved ejection fraction after catheter ablation |
| Date of disclosure of the study information | 2024/12/22 |
| Last modified on | 2024/12/21 17:56:52 |
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Basic information
Public title
The efficacy of heart failure medications in patients with heart failure with preserved ejection fraction after catheter ablation
Acronym
PROTECT-Atria
Scientific Title
The efficacy of heart failure medications in patients with heart failure with preserved ejection fraction after catheter ablation
Scientific Title:Acronym
PROTECT-Atria
Region
| Japan |
Condition
Condition
Heart failure with preserved ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively evaluate the superiority of the ARNI/SGLT2 group over the non-ARNI/SGLT2 group in the change in left atrial strain over time in post-catheter ablation patients with atrial fibrillation complicated by chronic heart failure, and the non-inferiority of the ARNI/SGLT2 group in the prognosis of chronic heart failure over the ARNI/SGLT2 group. The purpose of this study is to prospectively evaluate the non-inferiority of the ARNI/SGLT2 group to the non-ARNI/SGLT2 group in terms of prognosis of chronic heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Change in left atrial strain (reservoir strain, conduit strain, contractile strain) at 6 months after enrollment
Composite endpoint consisting of all-cause mortality and heart failure hospitalization at 6 months after enrollment
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
Prescription of SacbitrilValsaltan and Dapagliflogin in addition to other heart failure treatment
Interventions/Control_2
No medication or heart failure medications other than sacubitril valsartan and dapagliflozin
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
Patients must be free of AF recurrence at 6 months after the last catheter ablation for paroxysmal or persistent AF and have chronic heart failure.
Key exclusion criteria
Patients with left ventricular ejection fraction < 50%, prior cardiac surgery, unstable heart failure, patients under 20 years of age or of childbearing potential, patients already taking sacubitril valsartan and dapagliflozin, and patients who are judged by the attending physician to be difficult to use heart failure drugs in this study Patients with hypotension with systolic blood pressure < 100 mmHg, renal dysfunction with eGFR < 30 mL/min/1.73 m2 or creatinine clearance < 30 mL/min, hyperkalemia with potassium level > 5.0 mEq/L, diabetes requiring insulin injection or oral hypoglycemic agents), and Other cases deemed inappropriate by the attending physician
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Masuda |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular center
Zip code
6608511
Address
Inabaso3-1-69, Amagasaki, Hyogo, Japan
TEL
0664161221
masuda101@gmail.com
Public contact
Name of contact person
| 1st name | Masaharu |
| Middle name | |
| Last name | Masuda |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular center
Zip code
6620066
Address
3-1-69 Inabaso, Amagasaki, Japan
TEL
0664161221
Homepage URL
masuda101@gmail.com
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
Masaharu Masuda
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
Ethics committee of Kansai Rosai Hospital
Address
Inabaso 3-1-69, Amagasaki
Tel
0664161221
masuda101@gmail.com
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 | 12 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 09 | 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 | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064602
