Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-01-03 @ 9:19 AM
Study NCT ID:
NCT07270367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finerenone and Cardiac Remodeling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D020257', 'term': 'Ventricular Remodeling'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576501', 'term': 'finerenone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, double-blinded, randomized (1:1), placebo-controlled trial of finerenone vs placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Focal and Diffuse Fibrosis', 'timeFrame': '12 months', 'description': 'Effect on focal fibrosis (assessed by late gadolinium enhancement and diffuse fibrosis (assessed by extracellular volume using T1 mapping) measured by cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Myocardial Strain Parameters - left ventricular global longitudinal strain', 'timeFrame': '12 months', 'description': 'Effect on left ventricular global longitudinal strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Myocardial Strain Parameters - global circumferential strain', 'timeFrame': '12 months', 'description': 'Effect on global circumferential strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Myocardial Strain Parameters - global radial strain', 'timeFrame': '12 months', 'description': 'Effect on global radial strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Myocardial Strain Parameters - diastolic strain rate', 'timeFrame': '12 months', 'description': 'Effect on diastolic strain rate, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Myocardial Strain Parameters - right ventricular free wall strain', 'timeFrame': '12 months', 'description': 'Effect on right ventricular free wall strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Myocardial Strain Parameters - left atrial strain', 'timeFrame': '12 months', 'description': 'Effect on left atrial strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Myocardial Strain Parameters - right atrial strain', 'timeFrame': '12 months', 'description': 'Effect on right atrial strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'N-terminal pro-B-type natriuretic peptide (NT-proBNP) Levels', 'timeFrame': '12 months', 'description': 'Change in NT-proBNP concentration from baseline to 12 months of treatment with finerenone compared to placebo.'}], 'primaryOutcomes': [{'measure': 'Left ventricular mass indexed to baseline body surface area (LVMi)', 'timeFrame': '12 months', 'description': 'Change in LVMi (g/m\\^2), measured by cardiac magnetic resonance imaging (cMRI) from baseline to 12 months of treatment with finerenone compared to placebo. cMRI evaluations will be made from standard 2D views with and without gadolinium as a contrast agent. All acquired sequences will adhere to the current clinical standard of care.'}], 'secondaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '12 months', 'description': 'Change in LVEF, measured by cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Left Ventricular End-Diastolic Volume indexed to baseline body surface area (LVEDVi)', 'timeFrame': '12 months', 'description': 'Change in LVEDVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Left Ventricular End-Systolic Volume indexed to baseline body surface area (LVESVi)', 'timeFrame': '12 months', 'description': 'Change in LVESVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Right Ventricular Ejection Fraction (RVEF)', 'timeFrame': '12 months', 'description': 'Change in RVEF, measured by cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Right Ventricular End-Diastolic Volume indexed to baseline body surface area (RVEDVi)', 'timeFrame': '12 months', 'description': 'Change in RVEDVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Right Ventricular End-Systolic Volume indexed to baseline body surface area (RVESVi)', 'timeFrame': '12 months', 'description': 'Change in RVESVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.'}, {'measure': 'Left Atrial Volume indexed to baseline body surface area (LAVi)', 'timeFrame': '12 months', 'description': 'Change in LAVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Finerenone', 'Left Ventricle Remodeling', 'Double-blind', 'Randomized', 'Heart Failure', 'Multicentre', 'Cardiorenal'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '31240976', 'type': 'BACKGROUND', 'citation': 'Wang Y, Zhou R, Lu C, Chen Q, Xu T, Li D. 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Progression of Hypertrophy and Myocardial Fibrosis in Aortic Stenosis: A Multicenter Cardiac Magnetic Resonance Study. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007451. doi: 10.1161/CIRCIMAGING.117.007451.'}, {'pmid': '21492429', 'type': 'BACKGROUND', 'citation': 'Biederman RW, Magovern JA, Grant SB, Williams RB, Yamrozik JA, Vido DA, Rathi VK, Rayarao G, Caruppannan K, Doyle M. LV reverse remodeling imparted by aortic valve replacement for severe aortic stenosis; is it durable? A cardiovascular MRI study sponsored by the American Heart Association. J Cardiothorac Surg. 2011 Apr 14;6:53. doi: 10.1186/1749-8090-6-53.'}, {'pmid': '12106936', 'type': 'BACKGROUND', 'citation': 'Cicoira M, Zanolla L, Rossi A, Golia G, Franceschini L, Brighetti G, Marino P, Zardini P. Long-term, dose-dependent effects of spironolactone on left ventricular function and exercise tolerance in patients with chronic heart failure. 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Magn Reson Imaging. 2021 Feb;76:116-122. doi: 10.1016/j.mri.2020.11.011. Epub 2020 Nov 19.'}, {'pmid': '34729586', 'type': 'BACKGROUND', 'citation': 'Smiseth OA, Morris DA, Cardim N, Cikes M, Delgado V, Donal E, Flachskampf FA, Galderisi M, Gerber BL, Gimelli A, Klein AL, Knuuti J, Lancellotti P, Mascherbauer J, Milicic D, Seferovic P, Solomon S, Edvardsen T, Popescu BA; Reviewers: This document was reviewed by members of the 2018-2020 EACVI Scientific Documents Committee. Multimodality imaging in patients with heart failure and preserved ejection fraction: an expert consensus document of the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2022 Jan 24;23(2):e34-e61. doi: 10.1093/ehjci/jeab154.'}, {'pmid': '10760065', 'type': 'BACKGROUND', 'citation': 'Delcayre C, Silvestre JS, Garnier A, Oubenaissa A, Cailmail S, Tatara E, Swynghedauw B, Robert V. Cardiac aldosterone production and ventricular remodeling. Kidney Int. 2000 Apr;57(4):1346-51. doi: 10.1046/j.1523-1755.2000.00973.x.'}, {'pmid': '15599842', 'type': 'BACKGROUND', 'citation': "Okoshi MP, Yan X, Okoshi K, Nakayama M, Schuldt AJ, O'Connell TD, Simpson PC, Lorell BH. Aldosterone directly stimulates cardiac myocyte hypertrophy. J Card Fail. 2004 Dec;10(6):511-8. doi: 10.1016/j.cardfail.2004.03.002."}, {'pmid': '1453111', 'type': 'BACKGROUND', 'citation': 'Brilla CG, Weber KT. Mineralocorticoid excess, dietary sodium, and myocardial fibrosis. J Lab Clin Med. 1992 Dec;120(6):893-901.'}, {'pmid': '9220271', 'type': 'BACKGROUND', 'citation': 'Tanabe A, Naruse M, Naruse K, Hase M, Yoshimoto T, Tanaka M, Seki T, Demura R, Demura H. Left ventricular hypertrophy is more prominent in patients with primary aldosteronism than in patients with other types of secondary hypertension. Hypertens Res. 1997 Jun;20(2):85-90. doi: 10.1291/hypres.20.85.'}, {'pmid': '12105133', 'type': 'BACKGROUND', 'citation': 'Rossi GP, Di Bello V, Ganzaroli C, Sacchetto A, Cesari M, Bertini A, Giorgi D, Scognamiglio R, Mariani M, Pessina AC. Excess aldosterone is associated with alterations of myocardial texture in primary aldosteronism. Hypertension. 2002 Jul;40(1):23-7. doi: 10.1161/01.hyp.0000023182.68420.eb.'}, {'pmid': '35766038', 'type': 'BACKGROUND', 'citation': 'Buffolo F, Tetti M, Mulatero P, Monticone S. Aldosterone as a Mediator of Cardiovascular Damage. Hypertension. 2022 Sep;79(9):1899-1911. doi: 10.1161/HYPERTENSIONAHA.122.17964. Epub 2022 Jun 29.'}], 'seeAlsoLinks': [{'url': 'https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure', 'label': 'American Heart Association Inc. Classes and Stages of Heart Failure. American Heart Association.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the drug finerenone (Karendia) can improve heart function in participants who are at risk for heart and kidney disease.\n\nThe main question it aims to answer is whether adding finerenone to standard-of-care heart failure medical therapies will beneficially alter the heart structure and function of people who have risk factors for heart and kidney complications and whose left side of the heart is enlarged.\n\nThe researchers will compare finerenone to a placebo (a look-alike substance that contains no drug) to see if finerenone improves heart structure and function.\n\nParticipants will:\n\n* take a finerenone or a placebo tablet once a day for 12 months\n* have a cardiac magnetic resonance imaging (cMRI; a safe, non-invasive scan to measure heart mass, stiffness and function) test at the beginning of the study and 12 months later\n* visit the clinic after one, three, six and twelve months to assess overall health and/or perform blood or urine tests', 'detailedDescription': 'Finerenone is a potent and selective oral non-steroidal mineralocorticoid receptor antagonist that has demonstrated marked cardiovascular benefits in people living with diabetic kidney disease, heart failure with mildly reduced ejection fraction, and heart failure with preserved ejection fraction. However, the mechanistic basis of these broad cardiovascular benefits remains unclear.\n\nThe FINE-MECH CardioLink-11 trial is a multicentre, prospective, randomized, double-blind trial of finerenone vs placebo in addition to standard-of-care in adults with evidence of left ventricular hypertrophy and cardiorenal risk factors. A total of 156 individuals who provide written informed consent and meet all the inclusion criteria (and none of the exclusion criteria) will be assigned (1:1) to receive either finerenone or placebo QD for 12 months. There will be 6-7 clinic visits. Outcome assessors will be blinded to the investigational product allocation and the time point at which each assessment was completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals ≥18 years of age who are willing and able to provide signed informed consent\n* Evidence of left ventricular (LV) hypertrophy ≤12 months prior to or at screening showing at least one (≥1) of the following:\n\n 1. Interventricular septal (IVS) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm\n 2. Posterior wall (PW) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm\n 3. Left ventricular mass indexed to baseline body surface area (LVMi) by echocardiography: Female \\>95 g⁄m\\^2 or Male \\>115 g⁄m\\^2\n 4. LVMi (with papillary muscles included in the LV blood pool) by cMRI: Female \\>59 g⁄m\\^2 or Male \\>75 g⁄m\\^2\n 5. LVMi (if the papillary muscles are included in the LVM) by cMRI: Female \\>68 g⁄m\\^2 or Male \\>85 g⁄m\\^2\n* The presence of at least one (≥1) of the following risk factors:\n\n 1. History of heart failure with preserved ejection fraction (left ventricular ejection fraction \\[LVEF\\] ≥50%);\n 2. Type 2 diabetes mellitus;\n 3. Estimated glomerular filtration rate (eGFR) ≥25 and \\<75 mL/min/1.73 m\\^2;\n 4. Urine albumin-creatinine ratio (UACR) \\>3.39 mg/mmol and \\<565 mg/mmol;\n 5. Left atrial volume indexed to baseline body surface area (LAVi) \\>40 mL/m\\^2 (by echocardiography and as measured by either the biplane area-length method or Simpson's biplane method);\n 6. IVS ≥1.4 cm;\n 7. PW ≥1.4 cm;\n 8. LVMi ≥125 g⁄m\\^2 for males and ≥105 g⁄m\\^2 for females (by echocardiography);\n 9. N-terminal pro-B-type natriuretic peptide (NT-proBNP; within past 6 months) ≥150 pg/mL if in sinus rhythm or ≥450 pg/mL if atrial fibrillation is present.\n 10. Females who are of childbearing age can only be included if I. they are postmenopausal (i.e. no menstruation for at least one \\[≥1\\] year) or have had a surgical procedure ≥6 months at screening that prevents them from becoming pregnant; or II. the result of their pregnancy test at the baseline visit is negative, and they agree to use medically acceptable contraception methods to avoid pregnancy for the duration of the trial and for 1 month after taking the last dose of the assigned investigational product.\n\nExclusion Criteria:\n\n* Females who are planning to become pregnant, are breastfeeding or are planning to breastfeed;\n* Males who are planning to either father a child or donate sperm for the duration of the trial and for 1 month after taking the last dose of the assigned IP;\n* Serum potassium level ≥5 mmol/L at the time of screening;\n* eGFR \\<25 mL/min/1.73 m\\^2 at the time of screening or on kidney replacement therapy;\n* UACR ≥565 mg/mmol at the time of screening;\n* Seated systolic blood pressure \\<110 mmHg at the time of screening;\n* History of pulmonary arterial hypertension;\n* Type 1 diabetes mellitus;\n* Body mass index ≥40 kg/m\\^2;\n* Contraindication or inability to undergo MRI;\n* Known persistent hypoalbuminemia (≤30 g/L on \\>1 measurement within last 6 months);\n* Currently on a mineralocorticoid receptor antagonist (MRA) or in the opinion of the investigator, an MRA is either clinically indicated or contraindicated (e.g. history of marked hyperkalemia, marked hemodynamic stress, intolerance to MRAs) - individuals who previously experienced gynecomastia with spironolactone may be eligible if they meet all the inclusion criteria and none of the exclusion criteria;\n* Requirement of any intravenous (IV) vasodilating drug (e.g. nitrates, nitroprusside), any IV natriuretic peptide (e.g. nesiritide, carperitide), any IV positive inotropic agents, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) ≤24 hours prior to randomization;\n* Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin) or moderate or potent CYP3A4 inducers, that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period;\n* History of cardiac device implant (e.g. implantable cardioverter defibrillator/cardiac resynchronization therapy/pacemaker) or planned device implant ≤90 days after screening;\n* Hospitalized for heart failure (HF) requiring initiation or change in HF therapy or an urgent visit for HF requiring IV diuretic therapy, either ≤45 days prior to screening;\n* LVEF \\<40% per the most current echocardiogram or MRI;\n* Symptomatic bradycardia or second- or third-degree heart block without a pacemaker;\n* History of peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, right HF in the absence of left-sided structural disease, pericardial constriction, hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloidosis;\n* Myocardial infarction ≤45 days of screening;\n* Planned or previous cardiac surgery or major non-cardiac surgery ≤45 days of screening;\n* Planned or previous percutaneous coronary intervention ≤45 days of screening;\n* Stroke or transient ischemic stroke ≤90 days before randomization;\n* Severe valvular heart disease;\n* Addison's disease;\n* Individuals who are heart or kidney transplant recipients or who are (or are expected to be) listed for heart transplant, kidney dialysis or a kidney transplant ≤12 months of screening;\n* Any other known condition or therapy which would make the individual unsuitable for this trial (e.g. hepatic insufficiency, liver biomarkers \\>3X upper limit of normal, chronic pulmonary disease, life threatening arrhythmia, uncontrolled arrhythmia) or not allow participation for the full planned trial duration (e.g. active malignancy ≤24 months of screening or condition limiting life expectancy to \\<12 months);\n* Allergy to finerenone (or its excipients);\n* Allergy to gadolinium;\n* Participation in an investigational study ≤15 days prior to screening, or during study."}, 'identificationModule': {'nctId': 'NCT07270367', 'acronym': 'FINE-MECH', 'briefTitle': 'Finerenone and Cardiac Remodeling', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Medical and Surgical Knowledge Translation Research Group'}, 'officialTitle': 'Finerenone and Cardiac Remodeling: A Randomized, Double- Blind, Placebo-Controlled Study to Evaluate The Effects of Finerenone on Ventricular Remodeling', 'orgStudyIdInfo': {'id': 'CL-0011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Finerenone', 'description': 'Active treatment group', 'interventionNames': ['Drug: Finerenone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Control treatment group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Finerenone', 'type': 'DRUG', 'otherNames': ['Kerendia'], 'description': 'Participants will be allocated a starting dose of 10 or 20 mg of finerenone (dependent on kidney function) once daily, in addition to standard-of-care. Participants may be up-titrated or down-titrated based on potassium levels or estimated glomerular filtration rate with a minimum dose of 10 mg and maximum dose of 40 mg finerenone', 'armGroupLabels': ['Finerenone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will be allocated a starting dose of 10 or 20 mg of placebo (dependent on kidney function) once daily, in addition to standard-of-care. Participants may be up-titrated or down-titrated based on potassium levels or estimated glomerular filtration rate with a minimum dose of 10 mg and maximum dose of 40 mg placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1R6V6', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'A Shekhar Pandey, MD', 'role': 'CONTACT', 'email': 'pandey@cambridgecardiaccare.com', 'phone': '519-624-3511'}], 'facility': 'Cambride Cardiac Care Centre', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'M6B3H7', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Subodh Verma, MD, PhD', 'role': 'CONTACT', 'email': 'subodh.verma@nydcc.ca', 'phone': '416-783-0000'}], 'facility': 'North York Diagnostic and Cardiac Centre'}, {'zip': 'M1S4N6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Verma Subodh, MD, PhD', 'role': 'CONTACT', 'email': 'subodh.verma@nydcc.ca', 'phone': '416-291-7300'}], 'facility': 'Diagnostic Assessment Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Subodh Verma, MD, PhD', 'role': 'CONTACT', 'email': 'subodh.verma@nydcc.ca', 'phone': '416-864-5997'}], 'overallOfficials': [{'name': 'Subodh Verma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North York Diagnostic and Cardiac Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Subodh Verma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery and Pharmacology & Toxicology', 'investigatorFullName': 'Subodh Verma', 'investigatorAffiliation': 'Canadian Medical and Surgical Knowledge Translation Research Group'}}}}