Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 1:17 AM
Study NCT ID:
NCT03646357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2018-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-22', 'size': 1558187, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-22T10:07', 'hasProtocol': True}, {'date': '2025-03-18', 'size': 553413, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-21T12:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PROBE - prospective, randomized, open blinded end-point'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2895}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2035-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A composite of death of any cause, recurrent myocardial infarction, incident heart failure, coronary revascularization, ischemic stroke, malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Incidence of combined endpoint from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}], 'secondaryOutcomes': [{'measure': 'Recurrent MI', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to recurrent MI from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'All-cause death', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to a-cause Death from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Malignant ventricular arrhythmias including resuscitated cardiac arrest of cardiac origin', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Hospitalization or outpatient consultation for incident heart failure', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to hospitalization or outpatient consultation for heart failure from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Unplanned coronary revascularization', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to unplanned coronary revascularization from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Ischemic stroke', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to ischemic stroke from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Cardiovascular death', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to cardiovascular death from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Hospitalization for stable and unstable angina', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to hospitalization for stable and unstable angina from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Hospitalization for atrial fibrillation, atrial flutter or other atrial tachyarrhythmias', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to hospitalization for atrial fibrillation, atrial flutter or other atrial tachyarrhythmias from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Hospitalization for bradycardia, syncope or implantation of pacemaker', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to hospitalization for bradycardia, syncope or implantation of pacemaker from randomization. Estimated maximal follow-up for each patient for this outcome I 6 months to 6 years'}, {'measure': 'Hospitalization for chronic obstructive pulmonary disease, asthma or peripheral artery disease', 'timeFrame': '6 months (minimum) to 6 years (maximum)', 'description': 'Time to hospitalization for chronic obstructive pulmonary disease, asthma or peripheral artery disease from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years'}, {'measure': 'Angina symptoms', 'timeFrame': 'Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months', 'description': 'Canadian Cardiovascular Society (CCS) grading of angina pectoris.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months', 'description': 'Health-related quality of life measured by the Short Form (SF) 12'}, {'measure': 'Measures of depression and anxiety', 'timeFrame': 'Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months', 'description': 'HADS (Hospital Anxiety and Depression Scale)'}, {'measure': 'Measures of sexual dysfunction', 'timeFrame': 'Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months', 'description': 'The International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI)'}, {'measure': 'Measures of sleep disorders', 'timeFrame': 'Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months', 'description': 'Bergen insomnia Scale'}, {'measure': 'Measures of sleep disorders', 'timeFrame': 'Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months', 'description': 'Bergen insomnia Scale and sleep duration'}, {'measure': 'Measures of Nightmare Frequency', 'timeFrame': 'Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months', 'description': 'Nightmare Frequency Questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infarction', 'Myocardial Infarction', 'ST Elevation Myocardial Infarction', 'Non-ST Elevated Myocardial Infarction', 'Ischemia', 'Myocardial Ischemia', 'Heart Diseases', 'Cardiovascular Diseases', 'Metoprolol', 'Bisoprolol', 'Betablocker', 'Anti-Arrhythmia Agents', 'Physiological Effects of Drugs', 'Beta-blocker', 'Beta blocker'], 'conditions': ['Acute Myocardial Infarction', 'Non-ST Elevation Myocardial Infarction', 'ST Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '40888716', 'type': 'DERIVED', 'citation': 'Munkhaugen J, Kristensen AMD, Halvorsen S, Holmager T, Olsen MH, Bakken A, Sehested TSG, Ruddox V, Maeng M, Vikenes K, Jensen SE, Steigen T, Lambrechtsen J, Jortveit J, Bovin A, Schirmer H, Christiansen MK, Wiseth R, Mikkelsen D, Larsen AI, Kjaergaard CL, Andresen K, Gustafsson I, Tuseth V, Larsen ML, Deeg PS, Veien K, Bohmer E, Botker HE, Brattrud AO, Bronnum-Schou J, Pettersen AR, Bang LE, Oie E, Engstrom T, Borg EB, Kristensen K, Nymo SH, Gislason G, Vethe NT, Abdulla JAM, Dammen T, Mouridsen MR, Bendz B, Bertelsen MLN, Hove JD, Schierbeck L, Snoer M, Davidsen C, Egholm G, Thomsen KK, Jadou G, Poenaru M, Krarup NT, Bottcher M, Staehr PB, Zwisler AD, Edvardsen T, Torp-Pedersen C, Otterstad JE, Lange T, Fagerland MW, Atar D, Prescott E; BETAMI-DANBLOCK Investigators. Beta-Blockers after Myocardial Infarction in Patients without Heart Failure. N Engl J Med. 2025 Nov 13;393(19):1901-1911. doi: 10.1056/NEJMoa2505985. Epub 2025 Aug 30.'}, {'pmid': '36526898', 'type': 'DERIVED', 'citation': 'Granger CB, Pocock SJ, Gersh BJ. The need for new clinical trials of old cardiovascular drugs. Nat Rev Cardiol. 2023 Feb;20(2):71-72. doi: 10.1038/s41569-022-00819-1. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).', 'detailedDescription': "This is a prospective, randomized, open blinded end-point (PROBE) study. Patients with AMI will be randomized 1-8 days following PCI or thrombolysis, and allocated to either prescription of a BB or to no such prescription. Subjects will be followed up for at least 6 months (median 3 years) with respect to the primary and secondary endpoints. The primary end point, the key secondary end points, and most other secondary end points will be analysed and published jointly with data from the 'Danish Trial of Beta-blocker therapy after myocardial infarction without heart failure' (DANBLOCK) (NCT 03778554) (please see below).\n\nThe primary objective is to test whether oral BB therapy reduces the risk of all-cause death, recurrent MI, incident heart failure, unplanned coronary revascularization, ischemic stroke, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin compared to no such therapy, in patients with AMI treated with PCI or thrombolysis without reduced LVEF.\n\nThe key secondary objectives (planned for the main study) are:\n\n* To study whether oral BB therapy reduces the risk of each of the components of the primary end-point separately, compared to no such therapy\n* To assess clinical outcomes linked BB therapy in the following subgroups: age (tertiles\\< 70 years vs. ≥70 years), gender sex (men vs. women), country (Denmark vs Norway), BB dosage tertiles (dosage at randomization (\\<50 mg vs. ≥50 mg), hypertension (yes vs. no), diabetes (yes vs. no), diabetes (yes vs no), type of MI (STEMI vs. NSTEMI), and LVEF subgroups (preserved LVEF: ≥50% vs. mid-range LVEF: 40-49%).\n* To study whether oral BB therapy increases the risk of hospitalization for second or third-degree atrioventricular block or implantation of pacemaker.\n* To describe BB dosage and adherence at six months following randomization obtained from the national prescription registries\n* To assess study safety\n\nOther secondary objectives (for joint BETAMI-DANBLOCK sub-studies) are:\n\n* To study whether oral BB therapy reduces the risk of cardiovascular death compared to no such therapy\n* To study whether oral BB therapy reduces the risk of stable and unstable angina compared to no such therapy\n* To study whether oral BB therapy reduces the risk of atrial fibrillation, atrial flutter or other atrial tachyarrhythmias compared to no such therapy\n* To study whether oral BB therapy increases the risk of hospitalization for bradycardia or syncope.\n* To study whether oral BB therapy increases the risk of hospitalization for chronic obstructive pulmonary disease, asthma or peripheral artery disease.\n* To study whether oral BB therapy affects the following patient related outcomes:\n\nquality of life, angina, dyspnoea, anxiety, depression, sexual dysfunction or sleep disorders\n\n* To describe long term BB adherence obtained from the national prescription registries\n* To study sociodemographic, clinical, and psychosocial characteristics (PROMS and clinical data) between the two study arms and in the total sample\n* To conduct cost-utility analysis in relation to quality of life and a health economic evaluation including drug use, health care utilization, employment, income, and benefit take-up\n\nExploratory objectives (based on BETAMI data, only):\n\n* To study the proportion and predictors of non-adherence with BB, statins and other cardiovascular drugs assessed by direct methods quantifying drug concentrations in blood\n* Identify pharmacokinetic, pharmacogenetic and pharmacodynamic markers associated with side-effects and suboptimal response to treatment with cardiovascular drugs\n\nThe primary study end-points will be obtained through linkage to the Norwegian Cardiovascular Disease Registry and The Norwegian Population Registry (Folkeregisteret)\n\nSecondary endpoints will be obtained by linkage to the following national registries: The Norwegian Population Registry (Folkeregisteret), the Cause of Death Registry, the Norwegian Patient Registry, the Norwegian Cardiovascular Disease Registry, the Norwegian Prescription Database, the Norwegian registry for income, the FD-Trygd database (social security micro data for research) and the Control and payment of reimbursements to health service providers (KUHR) database. Further by collecting self-reported questionnaires and a clinical examination with blood sample collection.\n\nPrimary safety endpoints:\n\n• To describe the composite endpoint of malignant ventricular arrhythmias including resuscitated cardiac arrest of cardiac origin, incident heart failure, new MI or all-cause death at 30 days after randomization collected from i. direct telephone contact with the patient and from hospital medical records, ii. linkage to the Norwegian Cardiovascular Disease Registry and The Norwegian Population Registry at study end.\n\nOther safety endpoints:\n\n* To describe all-cause death at study end\n* To describe Suspected Unexpected Serious Adverse Reaction (SUSARs) during the follow-up period from the study database (continously reported by local investigators).\n\nRationale for combining data from the BETAMI study with the DANBLOCK (NCT03778554) study from Denmark: The trials have similar designs, only minor differences in study entry criteria, and were, from the very beginning, coordinated with the aim of conducting sub-studies on pooled data. However, the inclusion- and event rates have been lower than expected in both studies. To enhance feasibility, the final decision was made from both Steering Committees in May 2021 to combine the trials and publish initial results jointly. BETAMI and DANBLOCK will remain separate trials until the end of follow-up, where data from the trials will be combined and main results published together.\n\nSample size: A total of approximately 2900 patients from BETAMI will be recruited and randomized 1:1 to BB treatment (type and dosage according to treating physician) or no BB treatment within 8 days of MI. The study is event driven and a power calculation for the combined DANBLOCK-BETAMI trial has been performed in which 950 events will provide a power of 80% to detect a true treatment effect equal to a hazard ratio of 1.2 for no beta-blocker therapy. Follow-up: Patients will be followed from the randomization date until end of follow-up. The last patient included will be followed for a minimum of 6 months. Estimated mean (non) treatment duration is 3 (0.5-6) years.\n\nPost-trial objective:\n\n• To perform a joint analysis of the data from BETAMI-DANBLOCK with the REDUCE (NCT03278509), CAPITAL-RCT (NCT01155635) and REBOOT (NCT03596385) trials. This analysis will comprise approximately 19000 patients, giving increased power and precision for clinical decisions on both primary and secondary endpoints."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nTo be eligible for inclusion in the study, subjects must fulfill the following criteria at inclusion:\n\n* 18 years or older\n* Diagnosed with an acute MI type I according to the "Universal Definition of MI" (Defined as a detection of a rise and/or fall of cardiac biomarker value, preferably troponin, with at least one value above the 99th percentile upper reference limit and with at least one of the following; a) symptoms of ischemia, b) new or presumed new significant ST-segment-T wave changes or new left bundle branch block, c) development of pathological Q waves, d) imaging evidence of new loss of viable myocardium or e) identification of an intracoronary thrombus by coronary angiogram)\n* Must have been treated with PCI or thrombolysis during current hospitalization\n* Signed informed consent and expected cooperation of the patient according to ICH/GCP and national/local regulations\n* Have a national personal identification number and not be expected to emigrate during study\n\nExclusion Criteria\n\nStudy subjects must not meet any of the following criteria:\n\n* Having a condition where betablocker-therapy is required, including but not limited to:\n\n * Arrhythmias\n * Hypertension\n * Cardiomyopathies\n * Clinical diagnosis of heart failure\n * LVEF \\< 40% by echocardiography (by measurement and not only visual assessment for STEMI patients)\n * Left ventricular akinesia in ≥ 3 segments regardless of the LVEF\n* Contraindications to betablocker-therapy, including but not limited to:\n\n * Bradyarrhythmias\n * Hypotension\n * Severe peripheral artery disease\n * Previously known side-effects causing withdrawal\n * Severe chronic obstructive pulmonary disease\n * • Women of childbearing potential (a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)\n* Known hypersensitivity to any ingredient of the IMP\n* Other, according to the responsible investigator\n* End-stage somatic disease with short life expectancy, dementia, psychosis and other conditions could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible\n\nPrevious treatment with a betablocker is not an exclusion criterion for enrollment into the BETAMI study. Enrolled patients can participate in any other study that does not directly alter the effect betablocker treatment'}, 'identificationModule': {'nctId': 'NCT03646357', 'acronym': 'BETAMI', 'briefTitle': 'BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function (BETAMI)', 'orgStudyIdInfo': {'id': '2018-000590-75'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Betablocker', 'description': 'Patients receiving a betablocker. Any other treatment or management is to be given as per usual care.', 'interventionNames': ['Drug: Betablocker']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Betablocker', 'description': 'No betablocker is given to this arm. Any other treatment or management is to be given as per usual care.', 'interventionNames': ['Other: Non-betablocker']}], 'interventions': [{'name': 'Non-betablocker', 'type': 'OTHER', 'description': 'No betablocker will be administered. Patients randomized to no beta-blockade will be discouraged to use beta-blockade as long as there is no other indication than strictly secondary prevention after myocardial infarction. Any other treatment or management is to be given as per usual care.', 'armGroupLabels': ['Non-Betablocker']}, {'name': 'Betablocker', 'type': 'DRUG', 'description': 'A betablocker will be administered. To reflect contemporary management, for which this study is designed to test, there will not be a defined minimum dosage. The type and dose of BB will be left at the discretion of the PI. Generic drug and accepted dosages will be:\n\n* Metoprolol succinate up to a total dose of 200mg daily\n* Bisoprolol up to a total dose of 10mg daily\n* Carvedilol up to a total dose of 50mg daily\n\nThe treating physician will be encouraged to aim for an equipotent dose of 100 mg metoprolol succinate or higher. Any other treatment or management is to be given as per usual care.', 'armGroupLabels': ['Betablocker']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arendal', 'country': 'Norway', 'facility': 'Sørlandet Sykehus', 'geoPoint': {'lat': 58.46151, 'lon': 8.77253}}, {'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland Universitetssykehus', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Bodø', 'country': 'Norway', 'facility': 'Nordlandssykehuset HF Bodø', 'geoPoint': {'lat': 67.28267, 'lon': 14.37513}}, {'city': 'Drammen', 'country': 'Norway', 'facility': 'Drammen Hospital', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}, {'city': 'Fredrikstad', 'country': 'Norway', 'facility': 'Sykehuset Østfold Kalnes', 'geoPoint': {'lat': 59.2181, 'lon': 10.9298}}, {'city': 'Gjøvik', 'country': 'Norway', 'facility': 'Sykehuset Innlandet HF, Gjøvik Sykehus', 'geoPoint': {'lat': 60.79574, 'lon': 10.69155}}, {'city': 'Hamar', 'country': 'Norway', 'facility': 'Sykehuset Innlandet Hamar', 'geoPoint': {'lat': 60.7945, 'lon': 11.06798}}, {'city': 'Hønefoss', 'country': 'Norway', 'facility': 'Vestre Viken HF, Ringerike Sykehus', 'geoPoint': {'lat': 60.16804, 'lon': 10.25647}}, {'city': 'Lillehammer', 'country': 'Norway', 'facility': 'Sykehuset Innlandet Lillehammer', 'geoPoint': {'lat': 61.11514, 'lon': 10.46628}}, {'city': 'Lørenskog', 'country': 'Norway', 'facility': 'AHUS'}, {'city': 'Lørenskog', 'country': 'Norway', 'facility': 'LHL Gardermoen'}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Diakonhjemmet Sykehus', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Lovisenberg Diakonale Sykehus', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital Rikshospitalet, Dept.of Cardiology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital Ullevaal, Dept. of Cardiology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Sandvika', 'country': 'Norway', 'facility': 'Vestre Viken HF, Bærum Sykehus', 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}, {'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger Universitetssjukehus', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'city': 'Tromsø', 'country': 'Norway', 'facility': 'Universitetssykehuset Nord-Norge, UNN', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Tønsberg', 'country': 'Norway', 'facility': 'Vestfold hospital', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}], 'overallOfficials': [{'name': 'Dan Atar, MD Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, {'name': 'The Hospital of Vestfold', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, {'name': 'Nordlandssykehuset HF', 'class': 'OTHER'}, {'name': 'Lovisenberg Diakonale Hospital', 'class': 'OTHER'}, {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, {'name': 'Ostfold Hospital Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiology', 'investigatorFullName': 'Dan Atar', 'investigatorAffiliation': 'Oslo University Hospital'}}}}