An observational study in Left Bundle-Branch Block, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Observational
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.
The study's main objective is to evaluate the effect of LBBB on maximum functional capacity.
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.
The 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.
This 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.
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's enrollment of 162 is close to the median of 162 across 33 observational studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 73 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
For 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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with left bundle branch block in the absence of clinically detectable heart disease
Diagnostic Test: Cardiopulmonary exercise testing · Diagnostic Test: Echocardioghaphy
Subjects without left bundle branch block and in the absence of clinically detectable heart disease
Diagnostic Test: Cardiopulmonary exercise testing · Diagnostic Test: Echocardioghaphy
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.
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
Peak oxygen consumption
Peak oxygen consumption at peak exercise of a maximal symptom-limited cardiopulmonary exercise testing. Units peak oxygen consumption : mL/kg/min
Time frame: 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.
Left ventricular end-diastolic volume
Evaluate left ventricular end-diastolic indexed volume by echocardiography at rest. Unit: ml/m2
Time frame: 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.
Left ventricular ejection fraction
Evaluate left ventricular ejection fraction by echocardiography at rest. Unit: %
Time frame: 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.
Plan to share: Undecided — Undecided
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Ran from Dec 2022 to primary completion in Jul 2024, 18 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Fundación para la Investigación del Hospital Clínico de Valencia