Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients
NCT ID: NCT05335629
Last Updated: 2024-02-01
Study Results
Results pending
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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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
54 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-06-01
Study Completion Date
2023-10-01
Brief Summary
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A prospective, randomized, controlled study will be conducted at Clinical Cardioglogy department, Ain Shams University Hospitals, assessing the efficacy and tolerability of SGLT2 inhibitors (dapagliflozin) addition on the clinical outcome and cardiac remodeling markers of post myocardial infarction (MI) diabetic patients
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Detailed Description
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All patients presenting to the Clinical Cardiology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
Inclusion criteria:
1. Female or male aged \>18 and \< 75 years
2. Diabetic post myocardial infarction patients
3. First anterior STEMI with successful TIMI-3 flow
4. STEMI within 12 hrs of onset of chest pain
5. creatine clearance ≥60 mL/min
6. HbA1c between 6.5% and 12.0%
Exclusion criteria:
1. Cardiogenic shock on admission
2. Multivessel disease on admission
3. Mechanical complications e.g. mitral regurge on admission
4. Life threatening arrhythmia on admission
5. Hemodynamic instability on admission
6. Diagnosis of Type 1 diabetes mellitus
7. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
8. Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
9. Pregnant or breast-feeding patients
10. Active participation in another clinical study
11. AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN
12. CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
Eligible patients will be randomly assigned into one of 2 arms:
1. Group 1 (Healthy control) (n=10) Aged-matched healthy volunteers who do not suffer any diseases.
2. Group 2 (Control group) (n= 30): Post-MI patients who will receive standard of care for 4 Weeks
3. Group 3 (Test group) (n= 30): Post-MI patients who will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks
* Dapagliflozin will be administered immediately at time of PCI and daily for 4 weeks.
* Standard of care will given to both arms (group 2 and 3) and includes:
Dual Antiplatelet Therapy (DAPT), high intensity statin, anticoagulation therapy, ACEI or aldosterone antagonist depending on the ejection fraction
* All subjects will sign an informed consent statement prior to inclusion in the study.
* All subjects will be followed up for 4 weeks and blood samples will be withdrawn at baseline, 1 week, and the end of the study to test for ST2 (suppression of tumerogenicity 2) biomarker
Inclusion criteria:
1. Female or male aged \>18 and \< 75 years
2. Diabetic post myocardial infarction patients
3. First anterior STEMI with successful TIMI-3 flow
4. STEMI within 12 hrs of onset of chest pain
5. creatine clearance ≥60 mL/min
6. HbA1c between 6.5% and 12.0%
Exclusion criteria:
1. Cardiogenic shock on admission
2. Multivessel disease on admission
3. Mechanical complications e.g. mitral regurge on admission
4. Life threatening arrhythmia on admission
5. Hemodynamic instability on admission
6. Diagnosis of Type 1 diabetes mellitus
7. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
8. Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
9. Pregnant or breast-feeding patients
10. Active participation in another clinical study
11. AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN
12. CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
Eligible patients will be randomly assigned into one of 2 arms:
1. Group 1 (Healthy control) (n=10) Aged-matched healthy volunteers who do not suffer any diseases.
2. Group 2 (Control group) (n= 30): Post-MI patients who will receive standard of care for 4 Weeks
3. Group 3 (Test group) (n= 30): Post-MI patients who will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks
* Dapagliflozin will be administered immediately at time of PCI and daily for 4 weeks.
* Standard of care will given to both arms (group 2 and 3) and includes:
Dual Antiplatelet Therapy (DAPT), high intensity statin, anticoagulation therapy, ACEI or aldosterone antagonist depending on the ejection fraction
* All subjects will sign an informed consent statement prior to inclusion in the study.
* All subjects will be followed up for 4 weeks and blood samples will be withdrawn at baseline, 1 week, and the end of the study to test for ST2 (suppression of tumerogenicity 2) biomarker
Conditions
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Myocardial Infarction
Diabetes Mellitus, Type 2
Myocardial Remodeling, Ventricular
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Intervention arm
30 patients will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks
Interventions:
Drug: Dapagliflozin 10 mg oral tablets Standard of care: Dual antiplatelet therapy, Statin, anticoagulation therapy
Group Type
ACTIVE_COMPARATOR
Dapagliflozin 10Mg Tab
Intervention Type
DRUG
Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor) which is a new class of hypoglycemic drugs, and they can block sodium-dependent glucose transporter-2 (SGLT2) located in the early proximal renal tubule to increase urinary glucose excretion and decrease the concentration of blood glucose
Control arm
30 patients will receive standard of care (Dual antiplatelet therapy, Statin, anticoagulation therapy) for 4 weeks
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Dapagliflozin 10Mg Tab
Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor) which is a new class of hypoglycemic drugs, and they can block sodium-dependent glucose transporter-2 (SGLT2) located in the early proximal renal tubule to increase urinary glucose excretion and decrease the concentration of blood glucose
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Female or male aged \>18 and \< 75 years
2. Diabetic post myocardial infarction patients
3. First anterior STEMI with successful TIMI-3 flow
4. STEMI within 12 hrs of onset of chest pain
5. creatine clearance ≥60 mL/min
6. HbA1c between 6.5% and 12.0%
2. Diabetic post myocardial infarction patients
3. First anterior STEMI with successful TIMI-3 flow
4. STEMI within 12 hrs of onset of chest pain
5. creatine clearance ≥60 mL/min
6. HbA1c between 6.5% and 12.0%
Exclusion Criteria
1. Cardiogenic shock on admission
2. Multivessel disease on admission
3. Mechanical complications e.g. mitral regurge on admission
4. Life threatening arrhythmia on admission
5. Hemodynamic instability on admission
6. Diagnosis of Type 1 diabetes mellitus
7. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
8. Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
9. Pregnant or breast-feeding patients
10. Active participation in another clinical study
11. AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN
12. CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
2. Multivessel disease on admission
3. Mechanical complications e.g. mitral regurge on admission
4. Life threatening arrhythmia on admission
5. Hemodynamic instability on admission
6. Diagnosis of Type 1 diabetes mellitus
7. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
8. Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
9. Pregnant or breast-feeding patients
10. Active participation in another clinical study
11. AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN
12. CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Ain Shams University
OTHER
Sponsor Role
lead
Responsible Party
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Abdallah Heshmat
Clinical pharmacy demonstrator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Ain shams university hospitals
Cairo, , Egypt
Site Status
Countries
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Egypt
References
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Baker ML, Perazella MA. SGLT2 inhibitor therapy in patients with type-2 diabetes mellitus: is acute kidney injury a concern? J Nephrol. 2020 Oct;33(5):985-994. doi: 10.1007/s40620-020-00712-5. Epub 2020 Feb 18.
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BACKGROUND
Berezin AE, Berezin AA. Adverse Cardiac Remodelling after Acute Myocardial Infarction: Old and New Biomarkers. Dis Markers. 2020 Jun 12;2020:1215802. doi: 10.1155/2020/1215802. eCollection 2020.
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BACKGROUND
Bolognese L, Falsini G, Schwenke C, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. Impact of iso-osmolar versus low-osmolar contrast agents on contrast-induced nephropathy and tissue reperfusion in unselected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the Contrast Media and Nephrotoxicity Following Primary Angioplasty for Acute Myocardial Infarction [CONTRAST-AMI] Trial). Am J Cardiol. 2012 Jan 1;109(1):67-74. doi: 10.1016/j.amjcard.2011.08.006. Epub 2011 Sep 22.
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Broch K, Andreassen AK, Ueland T, Michelsen AE, Stueflotten W, Aukrust P, Aakhus S, Gullestad L. Soluble ST2 reflects hemodynamic stress in non-ischemic heart failure. Int J Cardiol. 2015 Jan 20;179:378-84. doi: 10.1016/j.ijcard.2014.11.003. Epub 2014 Nov 5.
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Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial. Eur Heart J. 2020 Sep 21;41(36):3421-3432. doi: 10.1093/eurheartj/ehaa419.
Reference Type
BACKGROUND
Gruzdeva O, Dyleva Y, Uchasova E, Akbasheva O, Karetnikova V, Kashtalap V, Shilov A, Polikutina O, Slepynina Y, Barbarash O. Biological markers and cardiac remodelling following the myocardial infarction. Aging (Albany NY). 2019 Jun 10;11(11):3523-3535. doi: 10.18632/aging.101994.
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BACKGROUND
Iwahana H, Yanagisawa K, Ito-Kosaka A, Kuroiwa K, Tago K, Komatsu N, Katashima R, Itakura M, Tominaga S. Different promoter usage and multiple transcription initiation sites of the interleukin-1 receptor-related human ST2 gene in UT-7 and TM12 cells. Eur J Biochem. 1999 Sep;264(2):397-406. doi: 10.1046/j.1432-1327.1999.00615.x.
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BACKGROUND
Januzzi JL Jr, Peacock WF, Maisel AS, Chae CU, Jesse RL, Baggish AL, O'Donoghue M, Sakhuja R, Chen AA, van Kimmenade RR, Lewandrowski KB, Lloyd-Jones DM, Wu AH. Measurement of the interleukin family member ST2 in patients with acute dyspnea: results from the PRIDE (Pro-Brain Natriuretic Peptide Investigation of Dyspnea in the Emergency Department) study. J Am Coll Cardiol. 2007 Aug 14;50(7):607-13. doi: 10.1016/j.jacc.2007.05.014. Epub 2007 Jul 30.
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Kokkoz C, Bilge A, Irik M, Dayangac HI, Hayran M, Akarca FK, Erdem NB, Cavus M. Prognostic value of plasma ST2 in patients with non-ST segment elevation acute coronary syndrome. Turk J Emerg Med. 2018 Feb 9;18(2):62-66. doi: 10.1016/j.tjem.2018.01.003. eCollection 2018 Jun.
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Lam CSP, Chandramouli C, Ahooja V, Verma S. SGLT-2 Inhibitors in Heart Failure: Current Management, Unmet Needs, and Therapeutic Prospects. J Am Heart Assoc. 2019 Oct 15;8(20):e013389. doi: 10.1161/JAHA.119.013389. Epub 2019 Oct 12. No abstract available.
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BACKGROUND
Li C, Zhang J, Xue M, Li X, Han F, Liu X, Xu L, Lu Y, Cheng Y, Li T, Yu X, Sun B, Chen L. SGLT2 inhibition with empagliflozin attenuates myocardial oxidative stress and fibrosis in diabetic mice heart. Cardiovasc Diabetol. 2019 Feb 2;18(1):15. doi: 10.1186/s12933-019-0816-2.
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Ma ZG, Yuan YP, Wu HM, Zhang X, Tang QZ. Cardiac fibrosis: new insights into the pathogenesis. Int J Biol Sci. 2018 Sep 7;14(12):1645-1657. doi: 10.7150/ijbs.28103. eCollection 2018.
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Mancini GB, Dahlof B, Diez J. Surrogate markers for cardiovascular disease: structural markers. Circulation. 2004 Jun 29;109(25 Suppl 1):IV22-30. doi: 10.1161/01.CIR.0000133443.77237.2f. No abstract available.
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McCarthy CP, Januzzi JL Jr. Soluble ST2 in Heart Failure. Heart Fail Clin. 2018 Jan;14(1):41-48. doi: 10.1016/j.hfc.2017.08.005.
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Millar NL, O'Donnell C, McInnes IB, Brint E. Wounds that heal and wounds that don't - The role of the IL-33/ST2 pathway in tissue repair and tumorigenesis. Semin Cell Dev Biol. 2017 Jan;61:41-50. doi: 10.1016/j.semcdb.2016.08.007. Epub 2016 Aug 10.
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Sanada S, Hakuno D, Higgins LJ, Schreiter ER, McKenzie AN, Lee RT. IL-33 and ST2 comprise a critical biomechanically induced and cardioprotective signaling system. J Clin Invest. 2007 Jun;117(6):1538-49. doi: 10.1172/JCI30634. Epub 2007 May 10.
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Santos-Gallego CG, Requena-Ibanez JA, San Antonio R, Ishikawa K, Watanabe S, Picatoste B, Flores E, Garcia-Ropero A, Sanz J, Hajjar RJ, Fuster V, Badimon JJ. Empagliflozin Ameliorates Adverse Left Ventricular Remodeling in Nondiabetic Heart Failure by Enhancing Myocardial Energetics. J Am Coll Cardiol. 2019 Apr 23;73(15):1931-1944. doi: 10.1016/j.jacc.2019.01.056.
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BACKGROUND
Schmitz J, Owyang A, Oldham E, Song Y, Murphy E, McClanahan TK, Zurawski G, Moshrefi M, Qin J, Li X, Gorman DM, Bazan JF, Kastelein RA. IL-33, an interleukin-1-like cytokine that signals via the IL-1 receptor-related protein ST2 and induces T helper type 2-associated cytokines. Immunity. 2005 Nov;23(5):479-90. doi: 10.1016/j.immuni.2005.09.015.
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Smith JN, Negrelli JM, Manek MB, Hawes EM, Viera AJ. Diagnosis and management of acute coronary syndrome: an evidence-based update. J Am Board Fam Med. 2015 Mar-Apr;28(2):283-93. doi: 10.3122/jabfm.2015.02.140189.
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Teh PP, Vasanthakumar A, Kallies A. Development and Function of Effector Regulatory T Cells. Prog Mol Biol Transl Sci. 2015;136:155-74. doi: 10.1016/bs.pmbts.2015.08.005. Epub 2015 Sep 26.
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Trajkovic V, Sweet MJ, Xu D. T1/ST2--an IL-1 receptor-like modulator of immune responses. Cytokine Growth Factor Rev. 2004 Apr-Jun;15(2-3):87-95. doi: 10.1016/j.cytogfr.2004.02.004.
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BACKGROUND
Tseng CCS, Huibers MMH, van Kuik J, de Weger RA, Vink A, de Jonge N. The Interleukin-33/ST2 Pathway Is Expressed in the Failing Human Heart and Associated with Pro-fibrotic Remodeling of the Myocardium. J Cardiovasc Transl Res. 2018 Feb;11(1):15-21. doi: 10.1007/s12265-017-9775-8. Epub 2017 Dec 28.
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Veeraveedu PT, Sanada S, Okuda K, Fu HY, Matsuzaki T, Araki R, Yamato M, Yasuda K, Sakata Y, Yoshimoto T, Minamino T. Ablation of IL-33 gene exacerbate myocardial remodeling in mice with heart failure induced by mechanical stress. Biochem Pharmacol. 2017 Aug 15;138:73-80. doi: 10.1016/j.bcp.2017.04.022. Epub 2017 Apr 25.
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Weinberg EO, Shimpo M, De Keulenaer GW, MacGillivray C, Tominaga S, Solomon SD, Rouleau JL, Lee RT. Expression and regulation of ST2, an interleukin-1 receptor family member, in cardiomyocytes and myocardial infarction. Circulation. 2002 Dec 3;106(23):2961-6. doi: 10.1161/01.cir.0000038705.69871.d9.
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BACKGROUND
Wojcik C, Warden BA. Mechanisms and Evidence for Heart Failure Benefits from SGLT2 Inhibitors. Curr Cardiol Rep. 2019 Sep 14;21(10):130. doi: 10.1007/s11886-019-1219-4.
Reference Type
BACKGROUND
Other Identifiers
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Dapagliflozin and ST2
Identifier Type: -
Identifier Source: org_study_id
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