Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT01759966
Status:
UNKNOWN
Last Update Posted:
2018-04-11
First Post:
2012-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomic Cardiovascular Control After Heart Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Blood samples for analyses of: genomic DNA, RNA-transcription in whole blood, cytokines, cathecholamines, other blood biomarkers\n2. Urine samples for analyses of: catecholamines, cortisol, other urine biomarkers\n3. Saliva samples for analyses of: cortisol\n4. Heart biopsy specimen for analyses of: acute and chronic rejection (routine surveillence procedure)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2012-12-28', 'studyFirstSubmitQcDate': '2012-12-28', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac allograft vasculopathy', 'timeFrame': '1 year', 'description': 'Indications of cardiac allograft vasculopathy (CAV), assessed by intravascular ultrasound (IVUS) during coronary catheterization.'}, {'measure': 'Acute rejections', 'timeFrame': '1 year', 'description': 'The frequency of acute rejections episodes and time to first rejection (combined time/event outcome), as assessed by analyses of heart biopsy specimens'}], 'secondaryOutcomes': [{'measure': 'Cardiac allograft vasculopathy', 'timeFrame': '3 years', 'description': 'Cf. above'}, {'measure': 'Acute rejections', 'timeFrame': '2 and 3 years', 'description': 'Cf. above'}, {'measure': 'Autonomic cardiovascular responses', 'timeFrame': '6 months, 1, 2 and 3 years', 'description': 'Autonomic cardiovascular responses (such as changes in blood pressures, heart rate, cardiac output, total peripheral resistance and heart rate variability) during head-up tilt-test, valsalva maneuver and isometric exercise'}, {'measure': 'Exercise capacity', 'timeFrame': '1, 2 and 3 years', 'description': 'Cardio-pulmonary responses to a standardized exercise tolerance test (treadmill), such as maximal oxygen consumption(maxVO2), heart rate increase, blood pressure increase, etc.'}, {'measure': 'Activity recordings', 'timeFrame': '6 months, 1, 2 and 3 years', 'description': 'Number of steps/day during 7 consecutive days, assessed by an accelerometer'}, {'measure': 'Hormonal levels', 'timeFrame': '6 months, 1, 2 and 3 years', 'description': 'The levels of catecholamines, cortisol and other hormones influenced by autonomic nervous activity in blood, urine and saliva'}, {'measure': 'General immune activity', 'timeFrame': '6 months, 1, 2 and 3 years', 'description': 'The blood levels of cytokines and other markers of immune function, as well as whole blood gene expression.'}, {'measure': 'Pain threshold', 'timeFrame': '6 months, 1, 2 and 3 years', 'description': 'Assessment of pain sensitivity by means of an algometer. Anatomically well-defined "trigger-points" are subjected to increasing pressure; the patients alert at the point where the pressure is perceived to be painful'}, {'measure': 'Clinical symptoms', 'timeFrame': '6 months, 1, 2 and 3 years', 'description': 'Validated questionnaires assessing: symptoms of autonomic dysfunction, quality of life, pain, fatigue, anxiety, depression and sleep problems.'}, {'measure': 'MetaIodoBenzylGuanidin-scan', 'timeFrame': '1 and 3 years', 'description': 'The degree of sympathetic cardiac reinnervation as assessed by the scintigraphic method MetaIodoBenzylGuanidin-scan'}, {'measure': 'Echocardiographic indices', 'timeFrame': '1, 2 and 3 years', 'description': 'Echocardiographic indices of cardiac function, such as as systolic and diastolic velocities of the ventricular myocardium based on Tissue Doppler Imaging'}, {'measure': 'Ambulant blood pressure recording', 'timeFrame': '1, 2 and 3 years', 'description': '24 hours ambulant blood pressure recordings'}, {'measure': 'Cardiac catheterization', 'timeFrame': '1, 2 and 3 years', 'description': 'Routine data from surveillance cardiac catheterization procedures, such as pressure recordings, angiograms and biopsy assessments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart transplantation', 'Autonomic cardiovascular control', 'Acute rejection', 'Cardiac allograft vasculopathy'], 'conditions': ['Heart Transplant Recipients']}, 'referencesModule': {'references': [{'pmid': '33323767', 'type': 'DERIVED', 'citation': 'Christensen AH, Nygaard S, Rolid K, Nytroen K, Gullestad L, Fiane A, Thaulow E, Dohlen G, Saul JP, Wyller VBB. Early Signs of Sinoatrial Reinnervation in the Transplanted Heart. Transplantation. 2021 Sep 1;105(9):2086-2096. doi: 10.1097/TP.0000000000003580.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective study is to investigate denervation (ie. surgical cutting of autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant recipients. More specifically, we focus on:\n\n1. The physiological consequences of denervation, in particular its consequences for clinical symptoms, orthostatic tolerance (ie. the ability to stand upright) and exercise capacity. We hypothesize that denervation has negative consequences for all these factors.\n2. The pathological consequences of denervation and reinnervation, in particular its association to acute rejection and coronary artery disease (cardiac allograft vasculopathy, CAV). We hypothesize that reinnervation protects against acute rejection and development of CAV\n3. Donor and recipient factors associated with the reinnervation process. We hypothesize that characteristics of the surgical procedure (such as aorta cross-clamp time) as well as the rehabilitation process of the recipient (such as physical activity) impacts on the reinnervation process.', 'detailedDescription': 'Heart transplantation is annually offered to more than 3500 patients worldwide. In Norway, the number is approximately 30/year, and all transplants are carried out at one single hospital (Oslo University Hospital, Rikshospitalet).\n\nNormally, the heart function is intimately controlled by the autonomic nervous system (ANS), but all nervous connections are lost during the surgical transplantation procedure, and the transplanted heart thus becomes denervated. In time, regrowth of nerves may cause partial reinnervation of the new heart.\n\nSome evidence suggests that reinnervation improves exercise capacity and reduces episodes of acute rejections and the development of cardiac allograft vasculopathy. The purpose of this study is further to investigate the changes over time with respect to all parts of the autonomic nervous system (the sympathetic, parasympathetic and sensoric part), and the associated physiological and pathological consequences.\n\nThe study may provide knowledge which ultimately could help us improve health and quality of live for heart transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is to enroll 50 Heart Transplant Recipients (HTRs) and 50 healthy control subjects.\n\nHTRs are consecutively invited to participate. Baseline investigations are carried out 7-12 weeks after transplantation surgery. Follow-up investigations are scheduled to 6 months and 1, 2 and 3 years after transplantation\n\nHealthy control subjects will be recruited to matcht the distribution of age and gender among HTRs. The will be examined at one time point only; thus, the healthy controls are not subjected to prospective follow-up.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria HTRs:\n\n* Completed heart transplantation during the last 7-12 weeks\n* Age \\> 16 years and \\< 70 years\n\nExclusion criteria HTRs:\n\n* Peri- or postoperative complications causing permanent dysfunction of the allograft (such as hyperacute rejection episodes, severe myocardial ischemia, etc.)\n* Diabetes with HbA1C \\> 6,5 % and/or manifest diabetic complications\n* Renal failure with plasma creatinine \\> 200 µmol/L\n* ECG abnormalities (scattered ectopic beats ad minor conduction problems are allowed)\n* Permanently bed-ridden\n\nInclusion criteria healthy controls:\n\n\\- Age and gender matching the HTRs\n\nExclusion criteria healthy controls:\n\n* Another chronic disease (such as diabetes mellitus)\n* Permanent use of pharmaceuticals (including hormone drugs)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01759966', 'acronym': 'AccHeart', 'briefTitle': 'Autonomic Cardiovascular Control After Heart Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Autonomic Cardiovascular Control After Heart Transplantation', 'orgStudyIdInfo': {'id': '2012/1428'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart transplant recipients', 'description': 'Patients receiving orthotopic heart transplant in the enrollment period'}, {'label': 'Healthy controls', 'description': 'Healthy control subjects, having the same age and sex distribution as the heart transplant recipients'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Dept. of Cardiology, Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Vegard B Wyller, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'South-Eastern Norway Regional Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD Dept of Pediatrics, Oslo University Hospital, Norway', 'investigatorFullName': 'Vegard Bruun Wyller', 'investigatorAffiliation': 'Oslo University Hospital'}}}}