Effects of Isolated LBBB on Maximal Functional Capacity

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Completed

Conditions: Left Bundle-Branch Block

Treatments: Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Echocardioghaphy

Study type: Observational

Funder types: Other

Identifiers

NCT05643404

2021/061

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult >18 years old
• ECG criteria of left bundle branch block (for controls without left bundle branch block )
• Provide informed consent

Exclusion criteria

• Inability to perform a maximal baseline exercise test;
• Structural heart disease, valve heart disease or diastolic dysfunction estimated by two-dimensional echocardiography;
• Previous ischemic heart disease, heart failure, myocardiopathy or myocarditis
• Effort angina during cardiopulmonary exercise testing (CPET);
• Any moderate pulmonary disease;
• Anaemia
• Left ventricular ejection fraction < 55%.

Trial design

162 participants in 2 patient groups

Isolated LBBB

Description:

Subjects with left bundle branch block in the absence of clinically detectable heart disease

Treatment:

Diagnostic Test: Echocardioghaphy

Diagnostic Test: Cardiopulmonary exercise testing

Matched controls without LBBB

Description:

Subjects without left bundle branch block and in the absence of clinically detectable heart disease

Treatment:

Diagnostic Test: Echocardioghaphy

Diagnostic Test: Cardiopulmonary exercise testing