Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
36 participants
INTERVENTIONAL
2022-12-01
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dapagliflozin group
Dapagliflozin 10 mg once a day and standard treatment
Dapagliflozin
Dapagliflozin 10 mg once daily in addition to standard therapy
Control group
Standard treatment only.
No interventions assigned to this group
Interventions
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Dapagliflozin
Dapagliflozin 10 mg once daily in addition to standard therapy
Eligibility Criteria
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Inclusion Criteria
* Heart failure in functional class II-III
* Dapagliflozin naive
Exception Criteria:
* Other significant valve diseases
* Pregnant or breastfeeding
* Unstable hemodynamic conditions including cardiogenic shock
* history of mitral valve replacement/repair or mitral balloon valvuloplasty
* history of hypoglycemia
* eGFR below 25 mmHg
* diffuse pulmonary fibrosis
18 Years
65 Years
ALL
No
Sponsors
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Universitas Sebelas Maret
OTHER
Responsible Party
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An Aldia Asrial
An Aldia Asrial, MD, FIHA (Principal investigator)
Principal Investigators
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An Aldia Asrial, MD
Role: PRINCIPAL_INVESTIGATOR
Universitas Sebelas Maret
Locations
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Sebelas Maret University Hospital
Sukoharjo, Central Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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Banerjee T, Mukherjee S, Ghosh S, Biswas M, Dutta S, Pattari S, Chatterjee S, Bandyopadhyay A. Clinical significance of markers of collagen metabolism in rheumatic mitral valve disease. PLoS One. 2014 Mar 6;9(3):e90527. doi: 10.1371/journal.pone.0090527. eCollection 2014.
Banerjee T, Mukherjee S, Biswas M, Dutta S, Chatterjee S, Ghosh S, Pattari S, Nanda NC, Bandyopadhyay A. Circulating carboxy-terminal propeptide of type I procollagen is increased in rheumatic heart disease. Int J Cardiol. 2012 Apr 5;156(1):117-9. doi: 10.1016/j.ijcard.2012.01.026. Epub 2012 Feb 1. No abstract available.
Lin YW, Chen CY, Shih JY, Cheng BC, Chang CP, Lin MT, Ho CH, Chen ZC, Fisch S, Chang WT. Dapagliflozin Improves Cardiac Hemodynamics and Mitigates Arrhythmogenesis in Mitral Regurgitation-Induced Myocardial Dysfunction. J Am Heart Assoc. 2021 Apr 6;10(7):e019274. doi: 10.1161/JAHA.120.019274. Epub 2021 Mar 20.
Nassif ME, Windsor SL, Tang F, Khariton Y, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Austin B, Drazner MH, Fong MW, Givertz MM, Gordon RA, Jermyn R, Katz SD, Lamba S, Lanfear DE, LaRue SJ, Lindenfeld J, Malone M, Margulies K, Mentz RJ, Mutharasan RK, Pursley M, Umpierrez G, Kosiborod M. Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial. Circulation. 2019 Oct 29;140(18):1463-1476. doi: 10.1161/CIRCULATIONAHA.119.042929. Epub 2019 Sep 16.
Ye Y, Bajaj M, Yang HC, Perez-Polo JR, Birnbaum Y. SGLT-2 Inhibition with Dapagliflozin Reduces the Activation of the Nlrp3/ASC Inflammasome and Attenuates the Development of Diabetic Cardiomyopathy in Mice with Type 2 Diabetes. Further Augmentation of the Effects with Saxagliptin, a DPP4 Inhibitor. Cardiovasc Drugs Ther. 2017 Apr;31(2):119-132. doi: 10.1007/s10557-017-6725-2.
Li G, Zhao C, Fang S. SGLT2 promotes cardiac fibrosis following myocardial infarction and is regulated by miR-141. Exp Ther Med. 2021 Jul;22(1):715. doi: 10.3892/etm.2021.10147. Epub 2021 May 3.
Other Identifiers
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Dapa-Rhemis
Identifier Type: -
Identifier Source: org_study_id
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