Effects of Isolated LBBB on Maximal Functional Capacity

NCT05643404 | Completed

• 1 other identifier: 2021/061
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Bundle-Branch Block

Keywords

Functional capacity; Cardiac dyssynchrony; Myocardial deformation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Isolated LBBB

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

Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Echocardioghaphy

Matched controls without LBBB

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

Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Echocardioghaphy

Interventions

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.

Isolated LBBB; Matched controls without LBBB

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

Isolated LBBB; Matched controls without LBBB

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Marta Peiro

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 40122231 DERIVED

MeSH Terms

Conditions

Bundle-Branch Block

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Patricia Palau, MD, PhD

  Instituto de Investigacion Sanitaria INCLIVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 8, 2022
• Study Start: December 22, 2022
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: August 21, 2024

Record last verified: 2023-09

Locations

ES (1)