Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01617551
Status:
UNKNOWN
Last Update Posted:
2014-03-04
First Post:
2012-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019323', 'term': 'omega-N-Methylarginine'}], 'ancestors': [{'id': 'D001120', 'term': 'Arginine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-01', 'studyFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional excretion of sodium after acute L-NMMA treatment', 'timeFrame': '1 month before and after CRD'}], 'secondaryOutcomes': [{'measure': 'Glomerular filtration rate (GFR) before and after L-NMMA treatment', 'timeFrame': '1 month before and after CRD'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Essential hypertension', 'Nitric oxide', 'Renal denervation', 'Sodium', 'GFR'], 'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans.\n\nTo Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-70 years\n* Stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic\n* Day-time ambulatory blood pressure \\> 145/75 mmHg\n\nExclusion Criteria:\n\n* Non compliance\n* Pregnancy/no-anticonception in fertile women\n* Radiocontrast allergy\n* Malignancy\n* Congestive heart failure (EF \\< 50)\n* eGFR \\< 45\n* Unstable angina pectoris\n* Recent myocardial infarction or PCI (\\< 6 mdr)\n* Secondary hypertension\n* Renal artery stenosis or multiple renal arteries on CT\n* Claudication'}, 'identificationModule': {'nctId': 'NCT01617551', 'acronym': 'RENO', 'briefTitle': 'Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'Effect of Renal Denervation on NO-mediated Regulation of Salt- and Water Excretion, Vasoactive Hormones and Tubular Transport Proteins in Patients With Resistant Hypertension', 'orgStudyIdInfo': {'id': 'RENO_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal denervation', 'description': 'Patient group randomized to renal denervation', 'interventionNames': ['Drug: NG-monomethyl-L-arginine (L-NMMA)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Patients randomized to sham procedure', 'interventionNames': ['Drug: NG-monomethyl-L-arginine (L-NMMA)']}], 'interventions': [{'name': 'NG-monomethyl-L-arginine (L-NMMA)', 'type': 'DRUG', 'description': 'Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour)', 'armGroupLabels': ['Renal denervation', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jesper N Bech, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. of medical research', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'centralContacts': [{'name': 'Jesper N Bech, MD, Ph.D', 'role': 'CONTACT', 'email': 'jnbech@dadlnet.dk', 'phone': '+45 41627639'}], 'overallOfficials': [{'name': 'Jesper N Bech, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of medical research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, Dr.Sci.', 'investigatorFullName': 'Erling Bjerregaard Pedersen', 'investigatorAffiliation': 'Regional Hospital Holstebro'}}}}