Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 8:05 PM
Study NCT ID:
NCT00885651
Status:
UNKNOWN
Last Update Posted:
2009-04-22
First Post:
2009-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-09-16', 'releaseDate': '2011-08-12'}, {'resetDate': '2011-11-23', 'releaseDate': '2011-10-19'}, {'resetDate': '2014-05-29', 'releaseDate': '2014-05-01'}], 'estimatedResultsFirstSubmitDate': '2011-08-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-21', 'studyFirstSubmitDate': '2009-04-20', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in stress-triggered response of catecholamines.', 'timeFrame': '2 weeks and 3 days'}], 'secondaryOutcomes': [{'measure': 'Change in stress-triggered blood pressure response.', 'timeFrame': '2 weeks and 3 days'}, {'measure': 'Change in stress-triggered pulse response.', 'timeFrame': '2 weeks and 3 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SNP', 'catecholamines', 'metoprolole', 'healthy subjects', 'physiological stress'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '22703382', 'type': 'DERIVED', 'citation': 'Petersen M, Andersen JT, Jimenez-Solem E, Broedbaek K, Hjelvang BR, Henriksen T, Frandsen E, Forman JL, Torp-Pedersen C, Kober L, Poulsen HE. Effect of the Arg389Gly beta(1)-adrenoceptor polymorphism on plasma renin activity and heart rate, and the genotype-dependent response to metoprolol treatment. Clin Exp Pharmacol Physiol. 2012 Sep;39(9):779-85. doi: 10.1111/j.1440-1681.2012.05736.x.'}]}, 'descriptionModule': {'briefSummary': 'Heart failure is a frequent disease in Denmark, and it is associated with very high mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000 hospitalizations every year due to this disease. From the time of diagnosis, patients survive an average of 4-5 years.\n\nA critical illness mechanism in heart failure is that these patients have high blood levels of catecholamines; epinephrine and norepinephrine, which is stress hormones from the sympathetic nervous system. Standard treatment of heart failure is with the two medical preparations betablockers and ACE-inhibitors.\n\nIt is not known what effect betablocker-treatment have on blood concentration of epinephrine and norepinephrine.\n\nIt is the purpose of this study, to investigate the effect of Selo-Zok ® (metoprolol) on the blood concentration of epinephrine and norepinephrine. This is done by creating a stress condition for the body, in this case with the bicycle test, while doing blood samples to determine the concentration of catecholamines. This will be done by 1-week treatment of tablet Selo-Zok ® followed by 1-week treatment of placebo (a substance with no medical effect). Blood samples will be taken to determine small changes in inheritance material (DNA) in the form of point mutations also called single nucleotide polymorphisms, since these changes can affect how we respond to metoprolol treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kaukaser\n* Healthy men\n* 18 years \\< age \\< 30 years\n* Non-smoker\n* 18 \\< BMI \\< 25\n* No chronic diseases\n* Motor-disability that disables completement of cardio-pulmonary exercise-test.\n\nExclusion Criteria:\n\n* Alcohol abuse or any other abuse\n* Intake of any narcotic drugs (example: cannabinoids, narcotics, stimulants of central nervous system, hypnotics, hallucinogenes)\n* Any of following medication:\n\n * astmamedication\n * heartmedication\n * antihistamines\n * antipsycotics\n * NSAIDs\n * rifampicine\n * chinidine\n * glucocorticoids\n* Abnormal ECG, particularly 2. or 3. degree AV-block, sinusbradycardia, sick sinusnode-syndrome, sign of heart failure or ischemia.\n* Allergy or intolerance of metoprolole\n* Lactoseallergy\n* 110 mmHg \\< Systolic blood pressure \\< 140 mmHg\n* 60 mmHg \\< Diastolic blood pressure \\< 90 mmHg\n* Bloodsucker \\> 11,1 mmol/L, or fasting, venous bloodsucker \\>= 7,0 (measured if: 7,8 \\< BS \\< 11,1)'}, 'identificationModule': {'nctId': 'NCT00885651', 'acronym': 'MEXICHO', 'briefTitle': 'Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'A Randomised, Double Blinded, Crossover Study of the Influence of Metoprolol on Exercise Induced Elevation of Catecholamines in Healthy Subjects.', 'orgStudyIdInfo': {'id': '13-5-23-9-3-8-15'}, 'secondaryIdInfos': [{'id': 'EudraCTnr. 2008-001908-23'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Metoprolol for 10 days followed by placebo for 7 days.', 'interventionNames': ['Drug: Metoprolole (Selo-Zok ®)', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo for 7 days followed by Metoprolol for 10 days', 'interventionNames': ['Drug: Metoprolole (Selo-Zok ®)', 'Drug: Placebo']}], 'interventions': [{'name': 'Metoprolole (Selo-Zok ®)', 'type': 'DRUG', 'description': 'Tablets, 200 mg, once a day, 10 days', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Henrik HP Enghusen Poulsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Universityhospital of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Morten Petersen, Department of Clinical Pharmacology, Rigshospitalet, Denmark', 'oldOrganization': 'Morten Petersen, Department of Clinical Pharmacology, Rigshospitalet, Denmark'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-08-12', 'type': 'RELEASE'}, {'date': '2011-09-16', 'type': 'RESET'}, {'date': '2011-10-19', 'type': 'RELEASE'}, {'date': '2011-11-23', 'type': 'RESET'}, {'date': '2014-05-01', 'type': 'RELEASE'}, {'date': '2014-05-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Henrik Enghusen Poulsen, Professor, Rigshospitalet, Denmark'}}}}