Left Bundle-Branch BlockNCT05643404
Effects of Isolated LBBB on Maximal Functional Capacity
An observational study of Left Bundle-Branch Block, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Bundle-Branch Block
- What is being tested?
- Cardiopulmonary exercise testing and Echocardioghaphy
- How many people
- 162 participants
- Where
- 1 siteSpain
- Study dates
- 22 Dec 2022to 9 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Adult >18 years old
- ECG criteria of left bundle branch block (for controls without left bundle branch block )
- Provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Isolated Left Bundle Branch Block 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.
Read the 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.
- Conditions
- Left Bundle-Branch Block
- Being tested
- Cardiopulmonary exercise testing, Echocardioghaphy
- Keywords
- Functional capacity, Cardiac dyssynchrony, Myocardial deformation
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testingDiagnostic 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.
EchocardioghaphyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Isolated LBBB | Subjects with left bundle branch block in the absence of clinically detectable heart disease Receives: 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 Receives: Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Echocardioghaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption
Peak oxygen consumption at peak exercise of a maximal symptom-limited cardiopulmonary exercise testing. Units peak oxygen consumption : mL/kg/min
Measured: 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
Evaluate left ventricular end-diastolic indexed volume by echocardiography at rest. Unit: ml/m2
Measured: 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
Evaluate left ventricular ejection fraction by echocardiography at rest. Unit: %
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start22 Dec 2022
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Bundle-Branch BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Palau, MD, PhD, Principal investigator, Instituto de Investigacion Sanitaria INCLIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643404
- Sponsor's protocol ID
- 2021/061
- Status last verified
- Sep 2023
- First submitted
- 22 Nov 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 40122231
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isolated Left Bundle Branch Block on Maximal Functional Capacity
- ClinicalTrials.gov ID
- NCT05643404
- Acronym / sponsor ID
- 2021/061
- Conditions
- Left Bundle-Branch Block
- Keywords
- Functional capacity, Cardiac dyssynchrony, Myocardial deformation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated LBBB | – | Diagnostic Test: Cardiopulmonary exercise testing, Diagnostic Test: EchocardioghaphySubjects with left bundle branch block in the absence of clinically detectable heart disease |
| Matched controls without LBBB | – | Diagnostic Test: Cardiopulmonary exercise testing, Diagnostic Test: EchocardioghaphySubjects without left bundle branch block and in the absence of clinically detectable heart disease |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Adult >18 years old
- ECG criteria of left bundle branch block (for controls without left bundle branch block )
- Provide informed consent
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testingMaximal 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. | Diagnostic test | Isolated LBBB, Matched controls without LBBB |
| EchocardioghaphyDoppler 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 | Diagnostic test | Isolated LBBB, Matched controls without LBBB |
Primary outcome
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
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 40122231Palau 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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Palau, MD, PhD principal investigator
Instituto de Investigacion Sanitaria INCLIVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Bundle-Branch Block, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.