Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT01840059
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Denervation in Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2013-04-17', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Symptoms', 'timeFrame': '12 months', 'description': 'Minnesota Living with Heart Failure Questionnaire'}, {'measure': 'Change in Exercise Function', 'timeFrame': '12 months', 'description': 'Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing'}, {'measure': 'Change in Heart Failure Biomarker', 'timeFrame': '12 months', 'description': 'BNP (Natriuretic peptide)'}, {'measure': 'Change in LV (Left Ventricle) filling pressure', 'timeFrame': '12 months', 'description': "E/E' on echocardiography"}, {'measure': 'Change in LV remodelling', 'timeFrame': '12 months', 'description': 'LV mass index'}, {'measure': 'Change in Left atrial (LA) size', 'timeFrame': '12 months', 'description': 'LA volume index'}], 'secondaryOutcomes': [{'measure': 'Change in Autonomic function', 'timeFrame': '3 and 12 months', 'description': 'Heart rate variability'}, {'measure': 'Change in Renal function', 'timeFrame': '3 and 12 months', 'description': 'Urea and Creatinine'}, {'measure': 'Change in Vascular function', 'timeFrame': '3 and 12 months', 'description': 'Aorta MRI (Magnetic Resonance Imaging)'}, {'measure': 'Change in Autonomic function', 'timeFrame': '3 and 12 months', 'description': 'mIBG radiotracer assessment'}, {'measure': 'Change in neurohormones', 'timeFrame': '3 and 12 months', 'description': 'Neurohormones'}, {'measure': 'Change in renal blood flow', 'timeFrame': '3 and 12 months', 'description': 'Renal MRI'}, {'measure': 'Change in Blood pressure', 'timeFrame': '3 and 12 months', 'description': 'ABPM (Ambulatory Blood Pressure Monitoring)'}, {'measure': 'Change in Endothelial function', 'timeFrame': '3 and 12 months', 'description': 'EndoPat'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac Failure', 'Autonomic Denervation'], 'conditions': ['Cardiac Failure']}, 'referencesModule': {'references': [{'pmid': '22392370', 'type': 'BACKGROUND', 'citation': 'Sobotka PA, Krum H, Bohm M, Francis DP, Schlaich MP. The role of renal denervation in the treatment of heart failure. Curr Cardiol Rep. 2012 Jun;14(3):285-92. doi: 10.1007/s11886-012-0258-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a treatment that lowers the activity of the sympathetic nervous system) is useful in the management of patients with heart failure with preserved ejection fraction (HF-PEF).', 'detailedDescription': 'Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in heart failure with preserved left ventricular ejection fraction. The current study aims to evaluate efficacy of renal sympathetic denervation for the modulation of the SNS in patients with HF-PEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* EF\\>40%\n* NHYA 2-3\n* Evidence of HF-PEF (mixture of dilated left atrium, left ventricular hypertrophy, raised E/E', elevated LVEDP/PCWP, raised BNP)\n\nExclusion Criteria:\n\n* Previously documented EF\\<40%\n* Hypertrophic, restrictive, dilated cardiomyopathy\n* Significant valvular heart disease\n* Unfavourable renal artery anatomy for renal denervation\n* eGFR\\<45\n* Contraindication to MRI\n* Myocardial infarction, unstable angina or cerebrovascular accident in last 3 months"}, 'identificationModule': {'nctId': 'NCT01840059', 'acronym': 'RDT-PEF', 'briefTitle': 'Renal Denervation in Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Royal Brompton & Harefield NHS Foundation Trust'}, 'officialTitle': 'A Randomised Controlled Trial Investigating the Effect of Transcatheter Renal Sympathetic Denervation on Symptoms and Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction.', 'orgStudyIdInfo': {'id': '2012HS001B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal sympathetic denervation', 'description': 'Renal denervation using the Medtronic Symplicity catheter.', 'interventionNames': ['Device: Renal sympathetic denervation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'HF-PEF patients who will serve as control.'}], 'interventions': [{'name': 'Renal sympathetic denervation', 'type': 'DEVICE', 'otherNames': ['Medtronic Symplicity Catheter'], 'description': 'A fit for purpose radiofrequency catheter is guided to the renal artery using fluoroscopy. This is connected to an external RF generator. RF energy is applied through the catheter to the renal artery wall with the goal of disrupting the sympathetic nerves which run in the adventitia', 'armGroupLabels': ['Renal sympathetic denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Carlo di Mario', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brompton & Harefield NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}