Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT01560312
Status:
TERMINATED
Last Update Posted:
2019-02-01
First Post:
2012-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Denervation in Refractory Hypertension
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'whyStopped': 'Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-03-21', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure difference', 'timeFrame': '6 months', 'description': 'Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring.'}], 'secondaryOutcomes': [{'measure': 'Blood pressure differences similar to primary outcome', 'timeFrame': '1 year, 2 years, 3 years', 'description': 'Systolic and Diastolic BP differences (comparison between baseline and evaluated time period) will be measured using 24-hours monitoring and also at office.'}, {'measure': 'Change of blood laboratory parameters and renal function', 'timeFrame': '6 months, 1, 2, 3 years', 'description': 'changes in blood concentrations of renin, aldosterone, metanephrines and renal function'}, {'measure': 'Post-denervation renal anatomy assessment', 'timeFrame': '1 year', 'description': 'CT angiography will be performed 1 year after RDN'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal denervation', 'Resistant hypertension', 'Spironolactone', 'Long-term Outcome'], 'conditions': ['Hypertension', 'Resistant to Conventional Therapy']}, 'descriptionModule': {'briefSummary': 'Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory hypertension with office SBP \\> 140 mmHg\n* SBP \\> 130 during 24-hours Holter blood pressure monitoring\n* Treatment with the least 3 antihypertensive medications including diuretics in optimal doses\n* Age \\> 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Secondary forms of hypertension\n* Chronic renal disease (serum creatinine \\> 200 umol/l)\n* Pregnancy\n* History of myocardial infarction or stroke in last 6 months\n* Severe valvular stenotic disease\n* Anatomic abnormalities and variants of renal artery including aneurysms, severe stenosis, reference diameter \\< 4 mm or length \\< 20 mm\n* Increased bleeding risk (thrombocytopenia \\< 50, INR \\> 1.5)'}, 'identificationModule': {'nctId': 'NCT01560312', 'acronym': 'PRAGUE-15', 'briefTitle': 'Renal Denervation in Refractory Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Renal Denervation - Hope for Patients With Refractory Hypertension?', 'orgStudyIdInfo': {'id': 'Charles University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal denervation', 'description': 'Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization)', 'interventionNames': ['Device: Renal denervation (Symplicity® Catheter System™)']}, {'type': 'NO_INTERVENTION', 'label': 'Medical treatment', 'description': "Conventional antihypertensive treatment including spironolactone (if not contraindicated).\n\nOne year after randomization, renal denervation can be performed according to the physician's decision based on the BP levels and if patient desires the procedure."}], 'interventions': [{'name': 'Renal denervation (Symplicity® Catheter System™)', 'type': 'DEVICE', 'description': '4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)', 'armGroupLabels': ['Renal denervation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Cardiocenter, University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Jiri Widimsky', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Třinec', 'country': 'Czechia', 'facility': 'Cardiocenter Podlesi', 'geoPoint': {'lat': 49.67763, 'lon': 18.67078}}], 'overallOfficials': [{'name': 'Petr Widimsky, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Prague, Czech Republic'}, {'name': 'Jiri Widimsky, Prof.MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'General University Hospital, Prague', 'class': 'OTHER'}, {'name': 'University Hospital Olomouc', 'class': 'OTHER'}, {'name': 'Cardiocenter Podlesí, Trinec, Czech Republic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiocenter, 3rd Faculty of Medicine', 'investigatorFullName': 'Petr Widimsky, MD', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}