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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05618223
Other study ID # Dapa-Rhemis
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date December 1, 2022
Est. completion date June 30, 2023

Study information

Verified date November 2022
Source Universitas Sebelas Maret
Contact An Aldia Asrial, MD
Phone +6281229663174
Email aaldiaa8@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rheumatic mitral stenosis remains a health problem in developing countries. Progressive fibrosis of the valves and myocardium is the main pathophysiology that plays an important role. Dapagliflozin has various beneficial effects on the heart by reducing fibrosis, reducing inflammation, and improving patient quality of life. However, the role of this therapy is unknown in patients with rheumatic mitral stenosis.


Description:

This study is an open-label study on Rheumatic Mitral Stenosis patients, carried out at Sebelas Maret University Hospital Sukoharjo, Panti Rahayu Hospital Purwodadi, and Permata Bunda Hospital Purwodadi. Researchers divided 36 Rheumatic Mitral Stenosis patients sequentially into two groups, the first was the dapagliflozin group which would receive dapagliflozin 10 mg once a day and standard treatment. And the second group will only get standard treatment. Each patient will be examined on PICP, MMP-1, MMP-1/TIMP-1 ratio, TGF-β, Net atrioventricular compliance index, NT-pro BNP, and Kansas City Cardiomyopathy Questionnaire on day 1 and one month after the intervention.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date June 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Severe mitral stenosis by echocardiographic examination of the planimetric method with morphology that supports the etiology of rheumatic - 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

Study Design


Intervention

Drug:
Dapagliflozin
Dapagliflozin 10 mg once daily in addition to standard therapy

Locations

Country Name City State
Indonesia Sebelas Maret University Hospital Sukoharjo Central Java

Sponsors (1)

Lead Sponsor Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Improvements of Biomolecular Parameters PICP in pg/ml, MMP-1 in pg/ml, MMP-1/TIMP-1 ratio, TGF-ß in pg/ml, NT-ProBNP in pg/ml 4 weeks
Primary Improvements of Clinical Parameters Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition) 4 weeks
Primary Improvements of Echocardiography Parameters Net atrioventricular compliance in mL/mmHG, mitral valve gradient in mmHg and mPAP in mmHg 4 weeks
Secondary Major Adverse Cardiac Events All cause cardiac rehospitalization 4 weeks
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