- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05799833
Low QRS Voltages in Young Healthy Individuals and Athletes
The Prevalence and Significance of Low QRS Voltages in Young Healthy Individuals and Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sabiha Gati, MBBS
- Phone Number: 07977 352296
- Email: s.gati@rbht.nhs.uk
Study Contact Backup
- Name: Nirmitha Jayaratne-Sandhu, MBBS
- Phone Number: 07977 352296
- Email: n.jayaratne@rbht.nhs.uk
Study Locations
-
-
-
London, United Kingdom, SW3 6NP
- Recruiting
- Royal Brompton Hospital
-
Contact:
- Sabiha Gati, MBBS
- Phone Number: 07977352296
- Email: s.gati@rbht.nhs.uk
-
Contact:
- Nirmitha Jayaratne-Sandhu, MBBS
- Phone Number: 07977352296
- Email: n.jayaratne@rbht.nhs.uk
-
Principal Investigator:
- Sabiha Gati, MBBS
-
Sub-Investigator:
- Nirmitha Jayaratne-Sandhu, MBBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
240 total study population:
- 60 athletes with low QRS voltage and 60 age and sex matched control group of athletes with normal QRS voltage
- 60 non-athletes with low QRS voltage and 60 age and sex matched controls with normal QRS voltage
Description
Inclusion Criteria:
- No cardiovascular symptoms
- Body mass index <30.
Exclusion Criteria:
- Individuals with cardiac symptoms;
- Past medical history of cardiac disease, previous myocarditis or lung disease;
- Individuals with pacemakers or defibrillators
- Family history of SCD <40 years old or cardiomyopathy
- Pregnant women
- Advanced kidney and/or liver disease
- Known thyroid disease,
- T-wave inversion or other training unrelated ECG changes
- Known significant valvular heart disease or intra-cardiac shunt on echocardiography.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Athletes with low QRS voltage
Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing. A subgroup of those identified to have low QRS voltage and myocardial scar on CMR will undergo genetic testing (anticipated number to be tested, N= 25) |
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor.
A subgroup (N=50 anticipated) will undergo genetic testing.
Other Names:
|
Young healthy individuals (non-athletes) with low QRS voltage
Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing. A subgroup of those identified to have low QRS voltage and myocardial scar on CMR will undergo genetic testing (anticipated number to be tested, N= 25) |
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor.
A subgroup (N=50 anticipated) will undergo genetic testing.
Other Names:
|
Age and sex matched control group of athletes with normal QRS voltage
Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing.
|
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor.
A subgroup (N=50 anticipated) will undergo genetic testing.
Other Names:
|
Age and sex matched young healthy controls (non-athletes) with normal QRS voltage
Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing.
|
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor.
A subgroup (N=50 anticipated) will undergo genetic testing.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of low QRS voltages in athletes and young non-athletic population on ECG analysis
Time Frame: 36 months
|
Prevalence data will be obtained from existing ECG database of athletes and young people who have been screened by Cardiac risk in the young.
|
36 months
|
Prevalence of myocardial fibrosis in the young athletic and non-athletic population with low QRS
Time Frame: 36 months
|
Participants satisfying inclusion criteria will undergo a cardiac MRI at a single time point to identify those with late gadolinium enhancement (indication of myocardial fibrosis)
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of individuals with low QRS complexes and myocardial fibrosis with rare protein altering variant in a cardiomyopathy gene.
Time Frame: 36 months
|
A subgroup of athletes and young health individuals with low QRS voltages and myocardial fibrosis on cardiac MRI will undergo genetic analysis to identify the presence of protein altering genetic variants in known cardiomyopathy causing genes
|
36 months
|
The proportion of individuals with low QRS complexes and myocardial fibrosis with exercise related ventricular premature beats or a ventricular premature beat burden of > 500 beats on a Holter monitor
Time Frame: 36 months
|
All participants will undergo cardiopulmonary exercise tests and 24 hour holter monitoring to identify presence of exercise related ventricular premature beats and a ventricular premature beat burden of > 500 beats on a Holter monitor
|
36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sabiha Gati, MBBS, Royal Brompton & Harefield NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Dilated Cardiomyopathy
- Cardiopulmonary exercise testing
- Athletes
- Cardiac magnetic resonance
- Sudden Cardiac Death
- Arrythmogenic right ventricular cardiomyopathy
- Myocardial fibrosis
- Implantable cardioverter defibrillator
- Late Gadolinium Enhancement
- Low QRS Voltage
- Low QRS amplitude
- Premature Ventricular complexes
- Arrhythmogenic Left Ventricular Cardiomyopathy
- Genetic inheritance
- Non sustained ventricular tachycardia
- Pre participation screening
- Sports screening
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Death, Sudden
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Cardiomegaly
- Laminopathies
- Heart Arrest
- Death
- Arrhythmias, Cardiac
- Cardiomyopathies
- Cardiomyopathy, Dilated
- Death, Sudden, Cardiac
- Arrhythmogenic Right Ventricular Dysplasia
Other Study ID Numbers
- 22IC7985
- WHCC_PA2965 (Other Grant/Funding Number: Royal Brompton Hospital charity)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dilated Cardiomyopathy
-
Bristol-Myers SquibbTerminatedPrimary Familial Dilated CardiomyopathyUnited States, Germany, Spain, United Kingdom
-
Hospital General Universitario Gregorio MarañonMinisterio de Sanidad, Servicios Sociales e IgualdadUnknownPrimary Idiopathic Dilated CardiomyopathySpain
-
Nantes University HospitalCompleted
-
IRCCS SYNLAB SDNCompletedPatients With Ischemic or Idiopathic Dilated CardiomyopathyItaly
-
Capricor Inc.National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsUnknownHeart Failure | Ischemic Cardiomyopathy | Nonischemic Cardiomyopathy | Dilated Cardiomyopathy (DCM)United States
-
Ray HershbergerNational Heart, Lung, and Blood Institute (NHLBI); National Human Genome Research...Active, not recruiting
-
University of TehranCompletedDilated CardiomyopathyIran, Islamic Republic of
-
McGill University Health Centre/Research Institute...Unknown
-
Chung Shan Medical UniversityCompletedPediatric Dilated CardiomyopathyTaiwan
-
Qingdao UniversityUnknownDilated CardiomyopathyChina
Clinical Trials on Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
-
University of MiamiRecruitingGlioma | Brain Tumor | Malignant Glioma | Primary Brain Tumor | Malignant Primary Brain TumorUnited States
-
Cedars-Sinai Medical CenterRecruitingCoronary Artery Disease | CancerUnited States
-
University of LeicesterUniversity Hospitals, LeicesterCompleted
-
Hospital Israelita Albert EinsteinUniversity of Sao PauloCompletedExposure to Magnetic Field | Uterine LeiomyomaBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustWithdrawn
-
Chinese University of Hong KongRecruitingParotid NeoplasmsHong Kong
-
OHSU Knight Cancer InstituteCompleted
-
University of AlbertaCanadian Urological Association Scholarship FoundationActive, not recruiting
-
NYU Langone HealthNational Institutes of Health (NIH)Recruiting
-
National Institute of Mental Health (NIMH)Recruiting