Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-29 @ 7:46 PM
Study NCT ID:
NCT04786769
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2021-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with heart failure hospital admission or cardiovascular death', 'timeFrame': 'up to 52 weeks', 'description': 'Analyzed as time-to-event'}], 'secondaryOutcomes': [{'measure': 'Total number of allogeneic RBC units received', 'timeFrame': '30 days post-TAVI or SAVR'}, {'measure': 'Walking distance', 'timeFrame': '6 months post-TAVI or SAVR', 'description': '6 minute walking test'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire', 'timeFrame': '6 months post-TAVI or SAVR', 'description': 'Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status.'}, {'measure': 'Patient Global Assessment', 'timeFrame': '6 months post-TAVI or SAVR', 'description': 'Patient reported outcome on the impact of the disease in daily live'}, {'measure': 'EQ-5D-5L', 'timeFrame': '6 months post-TAVI or SAVR', 'description': 'Quality of life assessment in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Stenosis', 'Iron-deficiency']}, 'referencesModule': {'references': [{'pmid': '33213729', 'type': 'BACKGROUND', 'citation': 'Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Nov 24;76(21):2492-2516. doi: 10.1016/j.jacc.2020.09.595.'}, {'pmid': '27040324', 'type': 'BACKGROUND', 'citation': 'Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.'}, {'pmid': '30871697', 'type': 'BACKGROUND', 'citation': 'Vemulapalli S, Dai D, Hammill BG, Baron SJ, Cohen DJ, Mack MJ, Holmes DR Jr. Hospital Resource Utilization Before and After Transcatheter Aortic Valve Replacement: The STS/ACC TVT Registry. J Am Coll Cardiol. 2019 Mar 19;73(10):1135-1146. doi: 10.1016/j.jacc.2018.12.049.'}, {'pmid': '33308468', 'type': 'BACKGROUND', 'citation': 'Myles PS, Richards T, Klein A. Preoperative intravenous iron for cardiac surgery. Lancet. 2020 Dec 12;396(10266):1883-1884. doi: 10.1016/S0140-6736(20)32406-5. No abstract available.'}, {'pmid': '28588077', 'type': 'BACKGROUND', 'citation': 'Abdul-Jawad Altisent O, Puri R, Regueiro A, Chamandi C, Rodriguez-Gabella T, Del Trigo M, Campelo-Parada F, Couture T, Marsal JR, Cote M, Paradis JM, DeLarochelliere R, Doyle D, Mohammadi S, Dumont E, Rodes-Cabau J. Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement. Circulation. 2017 Aug 15;136(7):632-643. doi: 10.1161/CIRCULATIONAHA.116.026349. Epub 2017 Jun 6.'}, {'pmid': '33272037', 'type': 'BACKGROUND', 'citation': 'Zimarino M, Barbanti M, Dangas GD, Testa L, Capodanno D, Stefanini GG, Radico F, Marchioni M, Amat-Santos I, Piva T, Saia F, Reimers B, De Innocentiis C, Picchi A, Toro A, Rodriguez-Gabella T, Nicolini E, Moretti C, Gallina S, Maddestra N, Bedogni F, Tamburino C. Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry. Circ Cardiovasc Interv. 2020 Dec;13(12):e009026. doi: 10.1161/CIRCINTERVENTIONS.120.009026. Epub 2020 Dec 4.'}, {'pmid': '33272032', 'type': 'BACKGROUND', 'citation': 'Costa F, Cohen MG. Transfusion and Mortality After Transcatheter Aortic Valve Replacement: Association or Causation? Circ Cardiovasc Interv. 2020 Dec;13(12):e010225. doi: 10.1161/CIRCINTERVENTIONS.120.010225. Epub 2020 Dec 4. No abstract available.'}, {'pmid': '23048055', 'type': 'BACKGROUND', 'citation': 'Nuis RJ, Rodes-Cabau J, Sinning JM, van Garsse L, Kefer J, Bosmans J, Dager AE, van Mieghem N, Urena M, Nickenig G, Werner N, Maessen J, Astarci P, Perez S, Benitez LM, Dumont E, van Domburg RT, de Jaegere PP. Blood transfusion and the risk of acute kidney injury after transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2012 Oct;5(5):680-8. doi: 10.1161/CIRCINTERVENTIONS.112.971291. Epub 2012 Oct 9.'}, {'pmid': '31902590', 'type': 'BACKGROUND', 'citation': 'Klein AA, Chau M, Yeates JA, Collier T, Evans C, Agarwal S, Richards T; UK Cardiac and Vascular Surgery Interventional Anaemia Response (CAVIAR) study team. Preoperative intravenous iron before cardiac surgery: a prospective multicentre feasibility study. Br J Anaesth. 2020 Mar;124(3):243-250. doi: 10.1016/j.bja.2019.11.023. Epub 2020 Jan 3.'}, {'pmid': '19920054', 'type': 'BACKGROUND', 'citation': 'Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.'}, {'pmid': '25176939', 'type': 'BACKGROUND', 'citation': 'Ponikowski P, van Veldhuisen DJ, Comin-Colet J, Ertl G, Komajda M, Mareev V, McDonagh T, Parkhomenko A, Tavazzi L, Levesque V, Mori C, Roubert B, Filippatos G, Ruschitzka F, Anker SD; CONFIRM-HF Investigators. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiencydagger. Eur Heart J. 2015 Mar 14;36(11):657-68. doi: 10.1093/eurheartj/ehu385. Epub 2014 Aug 31.'}, {'pmid': '26821594', 'type': 'BACKGROUND', 'citation': 'Jankowska EA, Tkaczyszyn M, Suchocki T, Drozd M, von Haehling S, Doehner W, Banasiak W, Filippatos G, Anker SD, Ponikowski P. Effects of intravenous iron therapy in iron-deficient patients with systolic heart failure: a meta-analysis of randomized controlled trials. Eur J Heart Fail. 2016 Jul;18(7):786-95. doi: 10.1002/ejhf.473. Epub 2016 Jan 28.'}, {'pmid': '31883356', 'type': 'BACKGROUND', 'citation': 'Ponikowski P, Kirwan BA, Anker SD, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Haboubi T, Keren A, Khintibidze I, Kragten H, Martinez FA, McDonagh T, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Jankowska EA. Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure. Eur J Heart Fail. 2019 Dec;21(12):1651-1658. doi: 10.1002/ejhf.1710. Epub 2019 Dec 28.'}, {'pmid': '33197395', 'type': 'BACKGROUND', 'citation': 'Ponikowski P, Kirwan BA, Anker SD, McDonagh T, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Gohring UM, Keren A, Khintibidze I, Kragten H, Martinez FA, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parkhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Lewis BS, Comin-Colet J, von Haehling S, Cohen-Solal A, Danchin N, Doehner W, Dargie HJ, Motro M, Butler J, Friede T, Jensen KH, Pocock S, Jankowska EA; AFFIRM-AHF investigators. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020 Dec 12;396(10266):1895-1904. doi: 10.1016/S0140-6736(20)32339-4. Epub 2020 Nov 13.'}, {'pmid': '32896294', 'type': 'BACKGROUND', 'citation': 'Richards T, Baikady RR, Clevenger B, Butcher A, Abeysiri S, Chau M, Macdougall IC, Murphy G, Swinson R, Collier T, Van Dyck L, Browne J, Bradbury A, Dodd M, Evans R, Brealey D, Anker SD, Klein A. Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial. Lancet. 2020 Oct 24;396(10259):1353-1361. doi: 10.1016/S0140-6736(20)31539-7. Epub 2020 Sep 5.'}, {'pmid': '30883058', 'type': 'BACKGROUND', 'citation': 'Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.'}, {'pmid': '29217006', 'type': 'BACKGROUND', 'citation': 'Durand E, Doutriaux M, Bettinger N, Tron C, Fauvel C, Bauer F, Dacher JN, Bouhzam N, Litzler PY, Cribier A, Eltchaninoff H. Incidence, Prognostic Impact, and Predictive Factors of Readmission for Heart Failure After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2426-2436. doi: 10.1016/j.jcin.2017.09.010.'}, {'pmid': '30883053', 'type': 'BACKGROUND', 'citation': "Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16."}]}, 'descriptionModule': {'briefSummary': 'The INERTIA trial is a multicenter double-blinded randomized trial of intravenous iron supplementation in patients with severe aortic stenosis and iron deficiency undergoing TAVI or SAVR. The primary endpoint is the time to HF hospital admission or cardiovascular death. Secondary endpoints will assess quality of life indicators and functional capacity at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe aortic stenosis\n* Enrolled for TAVI or SAVR procedures\n* Documented iron deficiency with either: Ferritin \\<100ug/L or Ferritin between 100-299ug/L and Transferrin Saturation \\< 20%.\n\nExclusion Criteria:\n\n* Use of packed red blood cells or whole blood in the past 3 months;\n* Use of erythropoietin-stimulating agent or IV iron in the past 3 months;\n* Use of oral or IV iron (\\>100mg/day) in the past 3 months;\n* Haemoglobin (Hb) levels \\> 15g/dL or \\< 8g/dL;\n* Active cancer;\n* Infection requiring antibiotic treatment at the time of first scheduled dose;\n* Any known contraindication to study intervention'}, 'identificationModule': {'nctId': 'NCT04786769', 'acronym': 'INERTIA', 'briefTitle': 'Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Santa Cruz, Portugal'}, 'officialTitle': 'A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency', 'orgStudyIdInfo': {'id': 'UNICARV-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron supplementation', 'description': 'Intravenous ferric carboxymaltose will be administered according to weight and hemoglobin values at randomization as follows:\n\n2-4 weeks before valve intervention On the day of admission to valve intervention (if determined by dose calculation, otherwise placebo) 12 weeks after valve intervention (if iron deficiency persists, otherwise placebo)', 'interventionNames': ['Drug: Ferric carboxymaltose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intravenous 0.9% NaCl (placebo) will be administered as follows:\n\n2-4 weeks before valve intervention On the day of admission to valve intervention 12 weeks after valve intervention', 'interventionNames': ['Drug: Ferric carboxymaltose']}], 'interventions': [{'name': 'Ferric carboxymaltose', 'type': 'DRUG', 'description': 'Intravenous ferric carboxymaltose according to baseline weight and hemoglobin', 'armGroupLabels': ['Iron supplementation', 'Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Afonso Félix-Oliveira, MSc', 'role': 'CONTACT', 'email': 'afonso.felix.oliveira@gmail.com', 'phone': '00351210433001'}], 'overallOfficials': [{'name': 'Afonso Félix-Oliveira, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Santa Cruz, Portugal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Santa Cruz, Portugal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Afonso Félix de Oliveira', 'investigatorAffiliation': 'Hospital de Santa Cruz, Portugal'}}}}