Effects of Isolated LBBB on Maximal Functional Capacity

Completed

• Conditions: Left Bundle-Branch Block
• Interventions: Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Echocardioghaphy

• Registration Number: NCT05643404
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-08
• Study Start: 2022-12-22
• Status Verified: 2023-09
• Primary Completion: 2024-07-09
• Study Completion: 2024-07-09
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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%.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Isolated LBBB	Cardiopulmonary exercise testing	Subjects with left bundle branch block in the absence of clinically detectable heart disease
Isolated LBBB	Echocardioghaphy	Subjects with left bundle branch block in the absence of clinically detectable heart disease
Matched controls without LBBB	Cardiopulmonary exercise testing	Subjects without left bundle branch block and in the absence of clinically detectable heart disease
Matched controls without LBBB	Echocardioghaphy	Subjects without left bundle branch block and in the absence of clinically detectable heart disease

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption	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.	Peak oxygen consumption at peak exercise of a maximal symptom-limited cardiopulmonary exercise testing. Units peak oxygen consumption : mL/kg/min

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	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.	Evaluate left ventricular ejection fraction by echocardiography at rest. Unit: %
Left ventricular end-diastolic volume	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.	Evaluate left ventricular end-diastolic indexed volume by echocardiography at rest. Unit: ml/m2

Trial Locations

Locations (1)

Marta Peiro; 🇪🇸 Valencia, Spain