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
150 participants
OBSERVATIONAL
2023-12-01
2025-04-01
Brief Summary
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Detailed Description
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* Heart failure (HF) is a progressive syndrome characterised by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues .
* The recent ESC/AHA/ACC guidelines of HF set medications as class 1 for the HF therapy as ACE-I/ ARNI/beta-blocker/MRA/ SGLT2 I as they reduced the risk of cardiovascular death and worsening HF in patients with HFrEF , Unless contraindicated or not tolerated.
* Empagliflozin is an orally available inhibitor sodium glucose co-transporter 2 receptor (SGLT-2), empagliflozin exerts its effect by preventing sodium and glucose reabsorption from proximal convoluted tubules. This leads to increased urinary sodium and glucose excretion, This is associated with a modest osmotic diuresis, blood pressure lowering effect, improvement in arterial stiffness , and decrease in heart rate.
* DAPA-HF trial shows: The primary outcome of cardiovascular death, HF hospitalization, for dapagliflozin vs. placebo, was 16.3% vs 21.2% (p \< 0.001).
* EMPA-REG OUTCOME trial shows: The primary outcome, cardiovascular death or HF hospitalization, for empagliflozin vs. placebo, was 19.4% vs. 24.7% ( p \< 0.001).
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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SGLT2I Group
the case group that will receive SGLT2I in the treatment
SGLT2 inhibitor
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
non - SGLT2I Group
the control group that will not receive SGLT2I in the treatment
No interventions assigned to this group
Interventions
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SGLT2 inhibitor
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients aged 18 years or older at time of inclusion in the study
* Patients with HF currently in NYHA class II-IV, or asymptomatic patients with proved mitral regurgitant lesion.
* Body Mass Index (BMI) \< 45 kg/m2
Exclusion Criteria
* Patient with implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac re-synchronization therapy (CRT) or implanted left ventricular assist device (LVAD)
* Diagnosis of cardiomyopathy induced by other etiologies rather than rheumatic heart disease eg, ischemia , dilated cardiomyopathy,…..etc within the 12 months prior to Visit 1
* Known allergy or hypersensitivity to SGLT-2 inhibitors
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* ongoing hematological diseases and malignancies
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Youssef Dandrawy
residant doctor
Principal Investigators
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Doaa A Fouad, MD
Role: STUDY_DIRECTOR
Assiut University
Magdy A Algowhary, MD
Role: STUDY_DIRECTOR
Assiut University
Ahmed G Bakry, MD
Role: STUDY_DIRECTOR
South Valley University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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gliflozins on rheumatic HF
Identifier Type: -
Identifier Source: org_study_id
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