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Completed

NCT Number: NCT05643404

Effects of Isolated LBBB on Maximal 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 study's main objective is to evaluate the effect of LBBB on maximum functional capacity.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marta Peiro

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

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.

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

Primary outcomes

  1. Peak oxygen consumption

    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.

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

Secondary outcomes

  1. Left ventricular end-diastolic volume

    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.

    Evaluate left ventricular end-diastolic indexed volume by echocardiography at rest. Unit: ml/m2

  2. Left ventricular ejection fraction

    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.

    Evaluate left ventricular ejection fraction by echocardiography at rest. Unit: %

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

Effects of Isolated Left Bundle Branch Block on Maximal Functional Capacity

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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