Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT01459900
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2011-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-19', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2011-10-25', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement', 'timeFrame': '3 months follow up', 'description': 'Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs.'}], 'secondaryOutcomes': [{'measure': 'ambulatory 24 hours BP measurements', 'timeFrame': '1, 3 and 6 months', 'description': 'Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.'}, {'measure': 'Echocardiography', 'timeFrame': '6 months', 'description': 'Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.'}, {'measure': 'Biomarkers', 'timeFrame': '1 months', 'description': 'Biomarkers concerning renal sodium excretion'}, {'measure': 'Applanation tonometry', 'timeFrame': '6 months', 'description': 'Pulse wave velocity, augmentation index, central BP estimates'}, {'measure': 'forearm plethysmography', 'timeFrame': '6 months', 'description': 'Forearm minimum vascular resistance'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Resistant Hypertension'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '28830251', 'type': 'DERIVED', 'citation': 'Peters CD, Mathiassen ON, Vase H, Bech Norgaard J, Christensen KL, Schroeder AP, Rickers HJVH, Opstrup UK, Poulsen PL, Langfeldt S, Andersen G, Hansen KW, Botker HE, Engholm M, Bertelsen JB, Pedersen EB, Kaltoft A, Buus NH. The effect of renal denervation on arterial stiffness, central blood pressure and heart rate variability in treatment resistant essential hypertension: a substudy of a randomized sham-controlled double-blinded trial (the ReSET trial). Blood Press. 2017 Dec;26(6):366-380. doi: 10.1080/08037051.2017.1368368. Epub 2017 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.\n\nExclusion Criteria:\n\n* Pregnancy\n* Non compliance\n* Heart Failure (NYHA 3-4)\n* LV ejection fraction \\< 50 %\n* Renal insufficiency (eGFR\\<30)\n* Unstable coronary heart disease\n* Coronary intervention within 6 months\n* Myocardial infarction within 6 months\n* Claudication\n* Orthostatic syncope within 6 months\n* Secondary Hypertension\n* Permanent atrial fibrillation\n* Significant Heart Valve Disease\n* Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH\n* Second and third degree heart block\n* Macroscopic haematuria\n* Proximal significant coronary stenosis\n* Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter \\< 4 mm, length \\< 2 cm, multiple renal arteries, severe calcifications)'}, 'identificationModule': {'nctId': 'NCT01459900', 'acronym': 'ReSET', 'briefTitle': 'Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital Skejby'}, 'officialTitle': 'Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial', 'orgStudyIdInfo': {'id': 'M-20110071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Renal artery ablation', 'description': 'By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away.', 'interventionNames': ['Procedure: Renal artery ablation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed.', 'interventionNames': ['Procedure: Renal angiography']}], 'interventions': [{'name': 'Renal artery ablation', 'type': 'PROCEDURE', 'description': 'Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.', 'armGroupLabels': ['Renal artery ablation']}, {'name': 'Renal angiography', 'type': 'PROCEDURE', 'description': 'Renal angiography by femoral access.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'country': 'Denmark', 'facility': 'Skejby Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Ole N Mathiassen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital, Dep. Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital Skejby', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Regionshospitalet Silkeborg', 'class': 'OTHER'}, {'name': 'Randers Regional Hospital', 'class': 'OTHER'}, {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}, {'name': 'Central Jutland Regional Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med', 'investigatorFullName': 'Ole Norling Mathiassen', 'investigatorAffiliation': 'Aarhus University Hospital Skejby'}}}}