Clinical trial NCT05643404: Effects of Isolated LBBB on Maximal Functional Capacity
Official title: Effects of Isolated Left Bundle Branch Block on Maximal Functional Capacity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Bundle-Branch Block
Keywords: Functional capacity
Cardiac dyssynchrony
Myocardial deformation
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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%.

Primary outcomes:
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.
Secondary outcomes:
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.
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.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Marta Peiro
Study officials:
affiliation: INCLIVA
name: Patricia Palau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: