Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT05643404
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Isolated LBBB on Maximal Functional Capacity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002037', 'term': 'Bundle-Branch Block'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak oxygen consumption', 'timeFrame': 'Eligible patients will perform only one cardiopulmonary exercise testing on the first visit. Peak oxygen consumption will be evaluated during the procedure and compared to control patients.', 'description': 'Peak oxygen consumption at peak exercise of a maximal symptom-limited cardiopulmonary exercise testing. Units peak oxygen consumption : mL/kg/min'}], 'secondaryOutcomes': [{'measure': 'Left ventricular end-diastolic volume', 'timeFrame': 'Eligible patients will perform only one echocardiography on the first visit. Left ventricular end-diastolic volume will be assessed during the procedure and compared to control patients.', 'description': 'Evaluate left ventricular end-diastolic indexed volume by echocardiography at rest. Unit: ml/m2'}, {'measure': 'Left ventricular ejection fraction', 'timeFrame': 'Eligible patients will perform only one echocardiography on the first visit. Left ventricular ejection fraction will be assessed during the procedure and compared to control patients.', 'description': 'Evaluate left ventricular ejection fraction by echocardiography at rest. Unit: %'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional capacity', 'Cardiac dyssynchrony', 'Myocardial deformation'], 'conditions': ['Left Bundle-Branch Block']}, 'referencesModule': {'references': [{'pmid': '40122231', 'type': 'DERIVED', 'citation': 'Palau P, Dominguez E, Minguez S, Nunez G, Santas E, Garcia-Conejo C, de Amo I, Marin P, Flor C, Lopez L, Ortega L, Gabaldon-Sanchez I, de la Espriella R, Sanchis J, Nunez J. Effect of left bundle branch block on maximal functional capacity in asymptomatic individuals without structural heart disease. Rev Esp Cardiol (Engl Ed). 2025 Nov;78(11):957-966. doi: 10.1016/j.rec.2025.03.001. Epub 2025 Mar 21. English, Spanish.'}]}, 'descriptionModule': {'briefSummary': "Left bundle branch block (LBBB) has been commonly associated with adverse cardiovascular (CV) events, but the effect of an isolated LBBB on maximal functional capacity is not well characterized.\n\nThe study's main objective is to evaluate the effect of LBBB on maximum functional capacity.", 'detailedDescription': 'Left bundle branch block (LBBB) has been commonly associated with adverse cardiovascular (CV) events, but the effect of an isolated LBBB on maximal functional capacity is not well characterized.\n\nThe main objective of the study is to evaluate the effect of LBBB on maximum functional capacity (objectively evaluated by the maximum oxygen consumption -VO2max- at peak exercise in a cardiopulmonary stress test -CPET-) in subjects with LBBB without known cardiovascular disease and compare these data with controls without LBBB.\n\nThis is a prospective study that will be carried out in a single centre. All patients with a diagnosis of LBBB and without evidence of structural heart disease in imaging tests will be enrolled. For each candidate with LBBB, one control without LBBB and matched for age, sex, body surface area, and daily physical activity will be selected. All included subjects will undergo a CPET and echocardiography. A sample size estimation \\[alpha: 0.05, power: 80%, and a clinically significant VO2max difference between groups of at least 10%\\] of 148 subjects (74 subjects with LBBB + 74 controls) would be necessary to test our hypothesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 74 consecutive adults with a previous diagnosis of isolated left bundle branch block recruited from general practitioner outpatient clinics will be included.\n\nFor each candidate with an isolated left bundle branch block, one control without a left bundle branch block and matched for age, sex, body surface area, and daily physical activity will be selected from general practitioner outpatient clinics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult \\>18 years old\n* ECG criteria of left bundle branch block (for controls without left bundle branch block )\n* Provide informed consent\n\nExclusion Criteria:\n\n* Inability to perform a maximal baseline exercise test;\n* Structural heart disease, valve heart disease or diastolic dysfunction estimated by two-dimensional echocardiography;\n* Previous ischemic heart disease, heart failure, myocardiopathy or myocarditis\n* Effort angina during cardiopulmonary exercise testing (CPET);\n* Any moderate pulmonary disease;\n* Anaemia\n* Left ventricular ejection fraction \\< 55%.'}, 'identificationModule': {'nctId': 'NCT05643404', 'briefTitle': 'Effects of Isolated LBBB on Maximal Functional Capacity', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Investigación del Hospital Clínico de Valencia'}, 'officialTitle': 'Effects of Isolated Left Bundle Branch Block on Maximal Functional Capacity', 'orgStudyIdInfo': {'id': '2021/061'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isolated LBBB', 'description': 'Subjects with left bundle branch block in the absence of clinically detectable heart disease', 'interventionNames': ['Diagnostic Test: Cardiopulmonary exercise testing', 'Diagnostic Test: Echocardioghaphy']}, {'label': 'Matched controls without LBBB', 'description': 'Subjects without left bundle branch block and in the absence of clinically detectable heart disease', 'interventionNames': ['Diagnostic Test: Cardiopulmonary exercise testing', 'Diagnostic Test: Echocardioghaphy']}], 'interventions': [{'name': 'Cardiopulmonary exercise testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing (CPET) on a bicycle ergometer, beginning with a workload of 10 W and increasing gradually in a ramp protocol at 10-W increments every 1 minute. We will define maximal functional capacity as when the patient stops pedalling because of symptoms, and the respiratory exchange ratio (RER) is ≥1.1. During exercise, patients were monitored with 12-lead electrocardiogram and blood pressure measurements every 2 minutes. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) will be defined as the highest value of oxygen consumption during the last 20 seconds of exercise.', 'armGroupLabels': ['Isolated LBBB', 'Matched controls without LBBB']}, {'name': 'Echocardioghaphy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Doppler echocardiogram examinations were performed under resting conditions using 2-dimensional echocardiography. Left ventricular end-diastolic volume and left ventricular ejection fraction will be measured according to the European Society of Echocardiography', 'armGroupLabels': ['Isolated LBBB', 'Matched controls without LBBB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Marta Peiro', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Patricia Palau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Investigacion Sanitaria INCLIVA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Investigación del Hospital Clínico de Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}