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The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT2I Group | the case group that will receive SGLT2I in the treatment |
| |
| non - SGLT2I Group | the control group that will not receive SGLT2I in the treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitor | Drug | case control study in which group will receive SGLT2I and group will not , to detect impact of the drug in changing NYHA class for heart failure and echographic parameter |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the clinical condition | improving or worsening in NYHA class: I- Ordinary physical activity does not cause undue fatigue, dyspnea, or palpitations. II- Ordinary physical activity causes fatigue, dyspnea, palpitations, or angina. III- Comfortable at rest; less than ordinary physical activity causes fatigue, dyspnea, palpitations, or angina. IV- Symptoms occur at rest; any physical activity increases discomfort. | 6 months up to 1 year |
| change of the function and regurge | improving or worsening in echocardiographic parameter :
| 6 months up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiovascular event | monitor rate for Cardiovascular death, non-fatal stroke, non-fatal myocardial infarction and hospitalization for HF between 2 groups | 6 months up to 1 year |
| Glomerular filtration rate affection |
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Inclusion Criteria:
Exclusion Criteria:
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Patients attending outpatient clinic, cardiology department, Assiut university hospital and south valley university hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Y Dandrawy, Bachelor | Contact | +201013086863 | ahmed_youssef200@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Doaa A Fouad, MD | Assiut University | Study Director |
| Magdy A Algowhary, MD | Assiut University | Study Director |
| Ahmed G Bakry, MD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24491689 | Background | Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5. | |
| 32865377 |
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| ID | Term |
|---|---|
| D012214 | Rheumatic Heart Disease |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012213 | Rheumatic Fever |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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|
monitor rate of decline in the estimated glomerular filtration rate between 2 groups
| 6 months up to 1 year |
| urinary tract infection | incidence of urinary tract infection between 2 groups by following urine analysis | 6 months up to 1 year |
| South Valley University |
| Study Director |
| Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28. |
| 25589482 | Background | Inzucchi SE, Zinman B, Wanner C, Ferrari R, Fitchett D, Hantel S, Espadero RM, Woerle HJ, Broedl UC, Johansen OE. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials. Diab Vasc Dis Res. 2015 Mar;12(2):90-100. doi: 10.1177/1479164114559852. Epub 2015 Jan 14. |
| 26343814 | Background | Chilton R, Tikkanen I, Cannon CP, Crowe S, Woerle HJ, Broedl UC, Johansen OE. Effects of empagliflozin on blood pressure and markers of arterial stiffness and vascular resistance in patients with type 2 diabetes. Diabetes Obes Metab. 2015 Dec;17(12):1180-93. doi: 10.1111/dom.12572. Epub 2015 Oct 9. |
| 30586757 | Background | Fitchett D, Inzucchi SE, Cannon CP, McGuire DK, Scirica BM, Johansen OE, Sambevski S, Kaspers S, Pfarr E, George JT, Zinman B. Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. Circulation. 2019 Mar 12;139(11):1384-1395. doi: 10.1161/CIRCULATIONAHA.118.037778. |
| 28285457 | Background | Zuhlke LJ, Beaton A, Engel ME, Hugo-Hamman CT, Karthikeyan G, Katzenellenbogen JM, Ntusi N, Ralph AP, Saxena A, Smeesters PR, Watkins D, Zilla P, Carapetis J. Group A Streptococcus, Acute Rheumatic Fever and Rheumatic Heart Disease: Epidemiology and Clinical Considerations. Curr Treat Options Cardiovasc Med. 2017 Feb;19(2):15. doi: 10.1007/s11936-017-0513-y. |
| 27188830 | Background | Carapetis JR, Beaton A, Cunningham MW, Guilherme L, Karthikeyan G, Mayosi BM, Sable C, Steer A, Wilson N, Wyber R, Zuhlke L. Acute rheumatic fever and rheumatic heart disease. Nat Rev Dis Primers. 2016 Jan 14;2:15084. doi: 10.1038/nrdp.2015.84. |
| 31535829 | Background | McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D045505 | Physiological Effects of Drugs |