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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolated LBBB | Subjects with left bundle branch block in the absence of clinically detectable heart disease |
| |
| Matched controls without LBBB | Subjects without left bundle branch block and in the absence of clinically detectable heart disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary exercise testing | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen consumption | Peak oxygen consumption at peak exercise of a maximal symptom-limited cardiopulmonary exercise testing. Units peak oxygen consumption : mL/kg/min | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular end-diastolic volume | Evaluate left ventricular end-diastolic indexed volume by echocardiography at rest. Unit: ml/m2 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Palau, MD, PhD | Instituto de Investigacion Sanitaria INCLIVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marta Peiro | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40122231 | Derived | 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. |
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| ID | Term |
|---|---|
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Echocardioghaphy | Diagnostic Test | 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 |
|
| Left ventricular ejection fraction |
Evaluate left ventricular ejection fraction by echocardiography at rest. Unit: % |
| 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. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |