Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 4:36 AM
Study NCT ID:
NCT05392959
Status:
TERMINATED
Last Update Posted:
2024-04-26
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'recruitment too slow', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the longitudinal change of the Fractional Flow Reserve (FRR)', 'timeFrame': 'up to 6 months', 'description': 'The longitudinal change (Δ) of FFR is defined as the value at follow-up (6 months) minus the value at baseline.\n\nThe complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform.\n\nIn the presence of coronary lesions, the degree of percent diameter stenosis will be measured by quantitative coronary angiography and their hemodynamic significance will be evaluated by measuring fractional flow reserve (FFR). According to the guidelines for myocardial revascularisation, only the lesions that have an FFR value equal or less than 0.8 will be treated by coronary angioplasty . In case of angioplasty, FFR will be also measured immediately after successful implantation of the coronary stent.'}, {'measure': 'the longitudinal change of the Coronary flow reserve (CFR)', 'timeFrame': 'up to 6 months', 'description': 'The longitudinal change (Δ) of CFR is defined as the value at follow-up (6 months) minus the value at baseline.\n\nThe complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform.\n\nCoronary flow reserve (CFR) will be measured in the vessels of interest, where FFR was measured.'}, {'measure': 'the longitudinal change of the Index of Microvascular Resistance (IMR).', 'timeFrame': 'up to 6 months', 'description': 'The longitudinal change (Δ) of IMR is defined as the value at follow-up (6 months) minus the value at baseline.\n\nThe complete assessment of the function of the coronary circulation will be performed by using a dedicated pressure and temperature equipped coronary guidewire (PressureWire X by Abbott Vascular) and the Coroventis CoroFlow software platform.\n\nThe Index of Microvascular Resistance (IMR) will be measured in the vessels of interest, where FFR was measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2', 'Dapagliflozin', 'Physiological Effects of Drugs', 'Coronary Artery Disease', 'Microcirculation', 'Fraction Flow Reserve', 'Index of Microcirculatory Resistance', 'Coronary Flow Reserve'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '20566676', 'type': 'BACKGROUND', 'citation': 'Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21.'}, {'pmid': '25538310', 'type': 'BACKGROUND', 'citation': 'Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015 Jan;38(1):140-9. doi: 10.2337/dc14-2441. No abstract available.'}, {'pmid': '27941935', 'type': 'BACKGROUND', 'citation': 'DeFronzo RA, Norton L, Abdul-Ghani M. Renal, metabolic and cardiovascular considerations of SGLT2 inhibition. Nat Rev Nephrol. 2017 Jan;13(1):11-26. doi: 10.1038/nrneph.2016.170. Epub 2016 Dec 12.'}, {'pmid': '20609968', 'type': 'BACKGROUND', 'citation': 'Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.'}, {'pmid': '27440828', 'type': 'BACKGROUND', 'citation': 'Wilding JP, Rajeev SP, DeFronzo RA. Positioning SGLT2 Inhibitors/Incretin-Based Therapies in the Treatment Algorithm. Diabetes Care. 2016 Aug;39 Suppl 2:S154-64. doi: 10.2337/dcS15-3005.'}, {'pmid': '27208375', 'type': 'BACKGROUND', 'citation': 'Abdul-Ghani M, Del Prato S, Chilton R, DeFronzo RA. SGLT2 Inhibitors and Cardiovascular Risk: Lessons Learned From the EMPA-REG OUTCOME Study. Diabetes Care. 2016 May;39(5):717-25. doi: 10.2337/dc16-0041.'}, {'pmid': '29306791', 'type': 'BACKGROUND', 'citation': 'Zhou H, Wang S, Zhu P, Hu S, Chen Y, Ren J. Empagliflozin rescues diabetic myocardial microvascular injury via AMPK-mediated inhibition of mitochondrial fission. Redox Biol. 2018 May;15:335-346. doi: 10.1016/j.redox.2017.12.019. Epub 2017 Dec 30.'}, {'pmid': '28231831', 'type': 'BACKGROUND', 'citation': 'Ott C, Jumar A, Striepe K, Friedrich S, Karg MV, Bramlage P, Schmieder RE. A randomised study of the impact of the SGLT2 inhibitor dapagliflozin on microvascular and macrovascular circulation. Cardiovasc Diabetol. 2017 Feb 23;16(1):26. doi: 10.1186/s12933-017-0510-1.'}, {'pmid': '28254770', 'type': 'BACKGROUND', 'citation': 'van Bommel EJM, Muskiet MHA, Tonneijck L, Kramer MHH, Nieuwdorp M, van Raalte DH. SGLT2 Inhibition in the Diabetic Kidney-From Mechanisms to Clinical Outcome. Clin J Am Soc Nephrol. 2017 Apr 3;12(4):700-710. doi: 10.2215/CJN.06080616. Epub 2017 Mar 2.'}, {'pmid': '25488697', 'type': 'BACKGROUND', 'citation': 'Scheen AJ. Pharmacodynamics, efficacy and safety of sodium-glucose co-transporter type 2 (SGLT2) inhibitors for the treatment of type 2 diabetes mellitus. Drugs. 2015 Jan;75(1):33-59. doi: 10.1007/s40265-014-0337-y.'}, {'pmid': '30415602', 'type': 'BACKGROUND', 'citation': 'Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.'}, {'pmid': '30882238', 'type': 'BACKGROUND', 'citation': 'Kato ET, Silverman MG, Mosenzon O, Zelniker TA, Cahn A, Furtado RHM, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Bonaca MP, Ruff CT, Desai AS, Goto S, Johansson PA, Gause-Nilsson I, Johanson P, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536. doi: 10.1161/CIRCULATIONAHA.119.040130. 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Role of variability in microvascular resistance on fractional flow reserve and coronary blood flow velocity reserve in intermediate coronary lesions. Circulation. 2001 Jan 16;103(2):184-7. doi: 10.1161/01.cir.103.2.184.'}, {'pmid': '8462157', 'type': 'BACKGROUND', 'citation': 'Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation. 1993 Apr;87(4):1354-67. doi: 10.1161/01.cir.87.4.1354.'}, {'pmid': '8124786', 'type': 'BACKGROUND', 'citation': 'De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. 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Epub 2014 Sep 1.'}, {'pmid': '8637515', 'type': 'BACKGROUND', 'citation': 'Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.'}, {'pmid': '7586302', 'type': 'BACKGROUND', 'citation': 'Pijls NH, Van Gelder B, Van der Voort P, Peels K, Bracke FA, Bonnier HJ, el Gamal MI. Fractional flow reserve. A useful index to evaluate the influence of an epicardial coronary stenosis on myocardial blood flow. Circulation. 1995 Dec 1;92(11):3183-93. doi: 10.1161/01.cir.92.11.3183.'}, {'pmid': '11447079', 'type': 'BACKGROUND', 'citation': 'De Bruyne B, Pijls NH, Bartunek J, Kulecki K, Bech JW, De Winter H, Van Crombrugge P, Heyndrickx GR, Wijns W. Fractional flow reserve in patients with prior myocardial infarction. 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Quantitative assessment of the coronary microvasculature: new tools for the black box. Circulation. 2013 Jun 18;127(24):2378-9. doi: 10.1161/CIRCULATIONAHA.113.003361. Epub 2013 May 16. No abstract available.'}, {'pmid': '23681066', 'type': 'BACKGROUND', 'citation': 'Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.'}, {'pmid': '15466646', 'type': 'BACKGROUND', 'citation': 'Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. doi: 10.1161/01.CIR.0000143893.18451.0E. Epub 2004 Oct 4.'}, {'pmid': '22874078', 'type': 'BACKGROUND', 'citation': "Ng MK, Yong AS, Ho M, Shah MG, Chawantanpipat C, O'Connell R, Keech A, Kritharides L, Fearon WF. The index of microcirculatory resistance predicts myocardial infarction related to percutaneous coronary intervention. Circ Cardiovasc Interv. 2012 Aug 1;5(4):515-22. doi: 10.1161/CIRCINTERVENTIONS.112.969048. Epub 2012 Aug 8."}, {'pmid': '25256535', 'type': 'BACKGROUND', 'citation': 'Hennigan B, Layland J, Fearon WF, Oldroyd KG. Fractional flow reserve and the index of microvascular resistance in patients with acute coronary syndromes. EuroIntervention. 2014 Aug;10 Suppl T:T55-63. doi: 10.4244/EIJV10STA10.'}, {'pmid': '29769166', 'type': 'BACKGROUND', 'citation': 'Xaplanteris P, Ntalianis A, De Bruyne B, Strisciuglio T, Pellicano M, Ciccarelli G, Milkas A, Barbato E. Coronary lesion progression as assessed by fractional flow reserve (FFR) and angiography. EuroIntervention. 2018 Oct 20;14(8):907-914. doi: 10.4244/EIJ-D-17-00872.'}, {'pmid': '26400825', 'type': 'BACKGROUND', 'citation': 'Zimmermann FM, Ferrara A, Johnson NP, van Nunen LX, Escaned J, Albertsson P, Erbel R, Legrand V, Gwon HC, Remkes WS, Stella PR, van Schaardenburgh P, Bech GJ, De Bruyne B, Pijls NH. Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial. Eur Heart J. 2015 Dec 1;36(45):3182-8. doi: 10.1093/eurheartj/ehv452. Epub 2015 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'Cardiovascular events remain a major driver of morbidity and mortality in patients with type 2 diabetes mellitus. Diffuse coronary atherosclerosis, combined with impairment of the microcirculation are frequent even in asymptomatic patients and can lead to unfavourable outcomes. In recent years, novel classes of antidiabetic drugs have been introduced, with salutary effects on cardiovascular outcomes of diabetic patients. The sodium-glucose linked transporter 2 (SGLT2) inhibitors - gliflozins - bind to the SGLT2 receptors of the proximal tubule of the nephron and cause glycosuria. They have been shown to have favourable cardiovascular effects by reducing deaths from cardiovascular causes in type 2 diabetic patients.\n\nMoreover, dapagliflozin reduces hospitalisation for heart failure in type 2 diabetic heart failure patients with and without reduced ejection fraction and reduces cardiovascular death and all causes mortality in those with reduced ejection fraction.\n\nIt is currently unknown if this is mediated by improvement of coronary physiology both at the level of the epicardial coronary arteries as well as the coronary microcirculation.\n\nThe purpose of the study is to explore the impact of dapagliflozin on the coronary and microcirculatory function of type 2 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes mellitus (T2DM) patients presenting with stable angina and a clinical indication for cardiac catheterization\n* T2DM patients with non ST elevation myocardial infarction (NSTEMI) or unstable angina referred for cardiac catheterization\n* Demonstration of coronary lesion(s) with non-significant fractional flow reserve (FFR) values (\\>0.80), for which revascularisation is deferred\n* Agreement to practice an acceptable method of birth control for women of childbearing potential\n* Signed patient informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* T2DM patients presenting with ST elevation myocardial infarction (STEMI)\n* Pregnancy or breastfeeding\n* Body mass index ≥45 kg/m2\n* Creatinine clearance ≤45 ml/min/1.73 m2 (as calculated by Modification of Diet in Renal Disease Study (MDRD ) formula for estimated Glomerular filtration rate (GFR))\n* Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal during screening or run-in phase\n* Uncontrolled hyperglycemia with glucose \\>240 mg/dL after an overnight fast\n* Stroke, or transient ischemic attack at presentation and up to 2 months prior to informed consent\n* Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake\n* Any uncontrolled endocrine disorder except type 2 diabetes\n* Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent\n* Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight\n* Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years\n* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells\n* Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption\n* Planned cardiac surgery or angioplasty within 3 months\n* Any clinical condition that would jeopardize patient safety while participating in this clinical trial\n* Life expectancy \\< 3 years'}, 'identificationModule': {'nctId': 'NCT05392959', 'acronym': 'DAPAMICRO', 'briefTitle': 'Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Effect of the Antidiabetic Drug DAPAgliflozin on the Coronary Macrovascular and MICROvascular Function in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'B0762021210908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The patient will be treated in standard of care for type 2 diabetic mellitus and will receive a placebo (1 tablet) administered orally daily during 24 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'dapagliflozin group', 'description': 'The patient will be treated in standard of care for type 2 diabetic mellitus and will receive Dapagliflozin 10 mg (1 tablet) administered orally daily during 24 weeks', 'interventionNames': ['Drug: Dapagliflozin 10 mg Tab']}], 'interventions': [{'name': 'Dapagliflozin 10 mg Tab', 'type': 'DRUG', 'otherNames': ['Forxiga®'], 'description': 'Dapagliflozin 10 mg per day', 'armGroupLabels': ['dapagliflozin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for dapagliflozin film-coated tablets 10 mg', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'state': 'Bruxelles-Capitale, Région de;Brussels Hoofdstedelijk Gewest', 'country': 'Belgium', 'facility': 'CHU Saint Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Panagiotis Xaplanteris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'panagiotis.xaplanteris@stpierre-bru.be'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}