Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-07 @ 11:15 AM
Study NCT ID:
NCT00480051
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2007-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESynchronisation in Patients With Heart Failure and a Normal QRS Duration
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058406', 'term': 'Cardiac Resynchronization Therapy'}], 'ancestors': [{'id': 'D002304', 'term': 'Cardiac Pacing, Artificial'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2007-05-29', 'studyFirstSubmitQcDate': '2007-05-29', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvements in 6-min walking distance', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire', 'timeFrame': '6 months'}, {'measure': 'Change in NT pro-BNP and echocardiographic parameters of LV function', 'timeFrame': '6 months'}, {'measure': 'Does MRI Dyssynchrony Index (CMR-TSI) predicts responders', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac Failure', 'Pacemaker', 'Dyssynchrony', 'Cardiac Magnetic Resonance', 'Narrow QRS'], 'conditions': ['Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '21339317', 'type': 'DERIVED', 'citation': 'Foley PW, Patel K, Irwin N, Sanderson JE, Frenneaux MP, Smith RE, Stegemann B, Leyva F. Cardiac resynchronisation therapy in patients with heart failure and a normal QRS duration: the RESPOND study. Heart. 2011 Jul;97(13):1041-7. doi: 10.1136/hrt.2010.208355. Epub 2011 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'Patients who have heart failure and have electrical evidence of delay in the contraction of the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing. Recent work has suggested that patients with heart failure who do not have electrical evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing out on a potentially important treatment advance.\n\nWe would like to study patients with heart failure who have normal ventricular activation on their ECGs to see whether we can predict those patients who will respond to biventricular pacing.', 'detailedDescription': 'AIMS and Objectives A randomised controlled clinical trial\n\nPrimary objective\n\n• Improvements in 6-min walking distance\n\nSecondary objectives Determine\n\n1. Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire\n2. Change in NT pro-BNP and echocardiographic parameters of LV function\n3. Does MRI Dyssynchrony Index (CMR-TSI) predicts responders.\n4. Morbidity and Mortality using CARE-HF definitions\n5. Packer combined clinical composite score\n\nStudy Design A pilot randomised controlled clinical trial 60 patients. The biventricular pacemaker with be optimized for both A-V delay and V-V delay.\n\nSubject Selection Source - Patients attending Good Hope Hospital, Sandwell Hospital Centres involved - 2 Eligible Participants - 60 patients with heart failure and narrow QRS.\n\nInclusion Criteria Sinus rhythm Symptomatic heart failure - NYHA class III or IV ECG QRS duration less than 120 milliseconds LV ejection fraction of less than 35% on echocardiography using Simpsons technique.\n\nAble to give informed consent\n\nExclusion Criteria Age below 18 Current or planned pregnancy Patient refusal Ventricular tachycardia or ventricular fibrillation Current or recent (within last 30 days) involvement in other studies Requires implantable cardioverter defibrillator (ICD) according to NICE criteria for implantation (England and Wales)\n\nDefinition of clinical response:- 20% improvement in 6 minute walk distance or any improvement from 0\n\nDefinition of echocardiographic response:- 15% or greater decrease in left ventricular end systolic volume\n\nFollow up 6 weeks and 6 monthly thereafter. Interim results at 6 months. Analysis of results, echocardiograms, MRI and BNP will be blind Walk distance to be measured by unblinded observer and by pedometer.\n\nRandomisation:\n\nNumbered envelopes will be prepared by sponsor (Heart of England NHS Foundation Trust) and kept from researchers. After informed consent, the patient will be enrolled and the technician will draw the result.\n\nThis trial was known as the Birmingham biventricular pacing in patients unselected for dyssynchrony (BIPIDS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sinus rhythm\n* Symptomatic heart failure - NYHA class III or IV\n* ECG QRS duration less than 120 milliseconds\n* LV ejection fraction of less than 35% on echo\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Age below 18\n* Current or planned pregnancy\n* Patient refusal\n* Ventricular tachycardia or ventricular fibrillation\n* Current or recent (within last 30 days) involvement in other studies\n* Requires implantable cardioverter defibrillator (ICD)'}, 'identificationModule': {'nctId': 'NCT00480051', 'acronym': 'RESPOND', 'briefTitle': 'RESynchronisation in Patients With Heart Failure and a Normal QRS Duration', 'organization': {'class': 'OTHER', 'fullName': 'Heart of England NHS Trust'}, 'officialTitle': 'RESynchronisation in Patients With Heart Failure and a Normal QRS Duration', 'orgStudyIdInfo': {'id': '2007CD002.GH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac Resynchronization Pacing', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B71 4HJ', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Sandwell Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B75 7RR', 'city': 'Sutton Coldfield', 'country': 'United Kingdom', 'facility': 'Good Hope Hospital', 'geoPoint': {'lat': 52.56667, 'lon': -1.81667}}], 'overallOfficials': [{'name': 'Francisco Leyva, MD MB BS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Birmingham'}, {'name': 'Paul W Foley, MB ChB MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart of England NHS Foundation Trust'}, {'name': 'Kiran Patel, PhD MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sandwell & West Birmingham Hospitals NHS Trust'}, {'name': 'Berthold Stegemann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bakken Research Centre, The Netherlands'}, {'name': 'Russell EA Smith, FRCP MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart of England NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sandwell & West Birmingham Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}