Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-29 @ 3:48 PM
Study NCT ID:
NCT01974557
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2013-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006337', 'term': 'Heart Murmurs'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2013-10-27', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of hemodynamic parameters', 'timeFrame': 'minutes', 'description': 'Invasive measurements using Swan-Ganz catheters and echocardiography will provide the data needed.'}], 'secondaryOutcomes': [{'measure': 'Composite of humoral markers', 'timeFrame': 'up to 1 hour', 'description': 'Blood samples will be analysed with regard to humoral peptides and hormones that may affect hemodynamics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac physiology', 'ageing', 'gender differences', 'diastole', 'fluid challenge'], 'conditions': ['Hemodynamics']}, 'referencesModule': {'references': [{'pmid': '36356959', 'type': 'DERIVED', 'citation': 'Andersen MJ, Wolsk E, Bakkestrom R, Christensen N, Carter-Storch R, Omar M, Dahl JS, Frederiksen PH, Borlaug B, Gustafsson F, Hassager C, Moller JE. Pressure-flow responses to exercise in aortic stenosis, mitral regurgitation and diastolic dysfunction. Heart. 2022 Nov 10;108(23):1895-1903. doi: 10.1136/heartjnl-2022-321204.'}, {'pmid': '31220623', 'type': 'DERIVED', 'citation': 'Andersen MJ, Wolsk E, Bakkestrom R, Thomsen JH, Balling L, Dahl JS, Gustafsson F, Moller JE, Hassager C. Hemodynamic Response to Rapid Saline Infusion Compared with Exercise in Healthy Participants Aged 20-80 Years. J Card Fail. 2019 Nov;25(11):902-910. doi: 10.1016/j.cardfail.2019.06.004. Epub 2019 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'Primary: To observe how hemodynamic parameters are affected by age during rest and exercise in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.\n\nSecondary: To thoroughly examine this population with regard to cardiac performance and function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary status, and humoral markers of organ functions. This population will serve as a healthy control group, to which different populations can be compared, hence the need for a comprehensive characterization.\n\nHypotheses:\n\nDiastolic function and parameters associated with diastolic function gradually deteriorate with increasing age. The gradual deterioration is unmasked at an earlier age during exercise and fluid challenge, compared to measurements made at rest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* No acute or chronic diseases that can influence hemodynamics\n* Pause in medication with effect on hemodynamics 24h before experimental day\n* Echocardiography, with no structural abnormalities with an impact on hemodynamics.\n* ECG without any pathological findings, including arrhythmia\n* Normal red and white blood count, normal renal, liver, thyroid, immune, and hematological function as well as normal electrolytes, HbA1c and natriuretic peptides\n* Ability to perform graded bicycle exercise testing\n* BMI in the range of 20-30 kg/m2\n* Height within population mean ±2 standard deviations\n* VO2-max within population mean ±2 standard deviations (age corrected)\n* Acceptable sonographic conditions\n* Informed consent\n\nExclusion Criteria:\n\n* History of heart failure (verified or suspected), or heart failure verified by pathological left and right systolic and diastolic measurements of the heart\n* Hypotension (systolic blood pressure \\< 100 mmHg)\n* Inability to participate\n* Pregnant women\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT01974557', 'acronym': 'HemReX', 'briefTitle': 'The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Effect of Age on the Hemodynamic Response During Rest and Exercise in Healthy Humans', 'orgStudyIdInfo': {'id': 'H-2-2013-072'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Exercise', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept. of Cardiology, Rigshospitalet, University Hospital of Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Finn Gustafsson, M.D. Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Physician'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finn Gustafsson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Finn Gustafsson', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}