Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT02146794
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2014-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Denervation in Chronic Heart Failure
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-21', 'studyFirstSubmitDate': '2014-05-19', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Left ventricular ejection fraction by Echocardiography', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '6 months', 'description': 'Renal denervation had been reported to cause a 30 mmHg fall in blood pressure when used in hypertension. Although in principle renal denervation might be favourable for physiology in chronic heart failure, numerous theoretical possibilities exist for the procedure causing deterioration in clinical status, including the possibility of a large fall in blood pressure.\n\nA deterioration in symptomatic status or occurrence of an event such as presyncope or syncope would be considered a primary outcome event.'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '6 months', 'description': 'Monitored as inpatient for 5 days, then as outpatient for 6 months'}, {'measure': 'Serum Creatinine', 'timeFrame': '6 months'}, {'measure': 'Serum sodium', 'timeFrame': '6 months'}, {'measure': 'Serum potassium', 'timeFrame': '6 months'}, {'measure': '6 minute walk distance', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '24603957', 'type': 'BACKGROUND', 'citation': 'Shun-Shin MJ, Howard JP, Francis DP. Removing the hype from hypertension. BMJ. 2014 Mar 6;348:g1937. doi: 10.1136/bmj.g1937. No abstract available.'}, {'pmid': '24480181', 'type': 'BACKGROUND', 'citation': 'Howard JP, Cole GD, Sievert H, Bhatt DL, Papademetriou V, Kandzari DE, Davies JE, Francis DP. Unintentional overestimation of an expected antihypertensive effect in drug and device trials: mechanisms and solutions. Int J Cardiol. 2014 Mar 1;172(1):29-35. doi: 10.1016/j.ijcard.2013.12.183. Epub 2014 Jan 8.'}, {'pmid': '23031283', 'type': 'RESULT', 'citation': 'Davies JE, Manisty CH, Petraco R, Barron AJ, Unsworth B, Mayet J, Hamady M, Hughes AD, Sever PS, Sobotka PA, Francis DP. First-in-man safety evaluation of renal denervation for chronic systolic heart failure: primary outcome from REACH-Pilot study. Int J Cardiol. 2013 Jan 20;162(3):189-92. doi: 10.1016/j.ijcard.2012.09.019. Epub 2012 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'Renal denervation can be carried out for heart failure', 'detailedDescription': 'There are theoretical reasons why renal denervation might be beneficial for patients with chronic heart failure. It is not known whether they would suffer large drops in blood pressure which might compromise safety.\n\nThis pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients were required to have chronic symptomatic systolic heart failure (NYHA class III or IV) on maximal tolerated medical therapy, including beta-blocker, ACE inhibitor or angiotensin receptor blocker, and spironolactone.\n\nExclusion Criteria:\n\n* Clinically unstable patients or those with significant valvular disease\n* An estimated glomerular filtration rate \\<35 ml/min\n* Unfavourable renal anatomy\n* Tortuous femoral arteries were not eligible'}, 'identificationModule': {'nctId': 'NCT02146794', 'acronym': 'REACH', 'briefTitle': 'Renal Denervation in Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Renal Denervation in Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'ICCH-10/065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal denervation', 'description': 'renal denervation', 'interventionNames': ['Device: Renal denervation']}], 'interventions': [{'name': 'Renal denervation', 'type': 'DEVICE', 'otherNames': ['Symplicity Renal Denervation System'], 'description': 'Renal denervation', 'armGroupLabels': ['Renal denervation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Darrel P Francis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Imperial College London'}, {'name': 'Justin E Davies, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}