Athletes HeartNCT03025737
Semmelweis Sport Study
An observational study of Athletes Heart, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
The aim of the present proposal is to investigate the development of distinct morphological, functional, biochemical and molecular aspects of short- and long-term sport-induced changes in the heart, to get a better understanding on the (patho)physiology of athlete's heart. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Athletes Heart
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2017to Jan 2020
- How long will I take part?
- 5 Years
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Elite, recreational, young and master athletes Healthy volunteers without a history of competitive physical exercise
Who may be able to join
- age
- no known cardiovascular disease
- history of sport activity (athletes)
- no history of competitive sport (controls)
Who cannot join
- History of known relevant cardiac disease (including cardiomyopathies)
- Contraindication to MRI or cardiopulmonary exercise testing
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Heart and Vascular Center, Semmelweis University
Budapest, 1122
Lilla Halász, +36206632509, merkely.study@gmail.com
About this study
Official title: Semmelweis Sport - Complex Cardiovascular Screening of Elite, Recreational, Young and Master Athletes
The aim of the present proposal is to investigate the development of distinct morphological, functional, biochemical and molecular aspects of short- and long-term sport-induced changes in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The main goal of our research is to deepen our knowledge on the proper differentiation between beneficial (physiological) and harmful (pathological) consequences of professional sport, thereby effectively preventing potential cardiovascular complications of athletes.
Read the detailed description
CLINICAL METHODS
- Sport specific questionnaire, patient history and physical examinations - In our detailed questionnaire, specific information is collected about quantity and quality of training, personal and family history and presence of sport specific and general symptoms.
- Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters associated with physical exercise are planned to be measured, such as cardiac biomarkers.
- 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
- Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
- Detailed echocardiography
- Detailed CMR examination
- Body composition analysis - With a sophisticated bio-electrical impedance analysis, comprehensive whole body composition and hydration analysis will be performed.
- Cardiopulmonary exercise testing - Sport specific protocols will be used on both treadmill and bike ergometers.
- Conditions
- Athletes Heart
- Keywords
- Hypertrophy, Left Ventricular, Ventricular Remodeling
- Medical subject headings
- Hypertrophy, Left Ventricular, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| athletes | Healthy highly trained elite athletes, recreational athletes, young and master athletes free of known structural myocardial disease | |
| controls | Healthy volunteers without a history of competitive physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis will be an investigation regarding the athletic adaptation using CMR
Measured: Baseline
Secondary outcomes (3)
The primary analysis will be an investigation regarding the athletic adaptation using cardiopulmonary exercise testing
Measured: Baseline
The primary analysis will be an investigation regarding the athletic adaptation using resting ECG
Measured: Baseline
The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletes HeartStudies 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
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Research, Development and Innovation Office, Hungary
- Responsible party
- Principal investigator, Bela Merkely, Semmelweis University Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025737
- Sponsor's protocol ID
- Semmelweis Sport
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semmelweis Sport - Complex Cardiovascular Screening of Elite, Recreational, Young and Master Athletes
- ClinicalTrials.gov ID
- NCT03025737
- Acronym / sponsor ID
- Semmelweis Sport
- Conditions
- Athletes Heart
- Keywords
- Hypertrophy, Left Ventricular, Ventricular Remodeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- National Research, Development and Innovation Office, Hungary
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- 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.
The aim of the present proposal is to investigate the development of distinct morphological, functional, biochemical and molecular aspects of short- and long-term sport-induced changes in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The main goal of our research is to deepen our knowledge on the proper differentiation between beneficial (physiological) and harmful (pathological) consequences of professional sport, thereby effectively preventing potential cardiovascular complications of athletes.
Detailed description
CLINICAL METHODS
- Sport specific questionnaire, patient history and physical examinations - In our detailed questionnaire, specific information is collected about quantity and quality of training, personal and family history and presence of sport specific and general symptoms.
- Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters associated with physical exercise are planned to be measured, such as cardiac biomarkers.
- 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
- Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
- Detailed echocardiography
- Detailed CMR examination
- Body composition analysis - With a sophisticated bio-electrical impedance analysis, comprehensive whole body composition and hydration analysis will be performed.
- Cardiopulmonary exercise testing - Sport specific protocols will be used on both treadmill and bike ergometers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| athletes | – | –Healthy highly trained elite athletes, recreational athletes, young and master athletes free of known structural myocardial disease |
| controls | – | –Healthy volunteers without a history of competitive physical exercise |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elite, recreational, young and master athletes Healthy volunteers without a history of competitive physical exercise
Key inclusion criteria (4 listed)
- age
- no known cardiovascular disease
- history of sport activity (athletes)
- no history of competitive sport (controls)
Key exclusion criteria (2 listed)
- History of known relevant cardiac disease (including cardiomyopathies)
- Contraindication to MRI or cardiopulmonary exercise testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary analysis will be an investigation regarding the athletic adaptation using CMR
Time frame: Baseline
3 secondary outcomes
The primary analysis will be an investigation regarding the athletic adaptation using cardiopulmonary exercise testing
Time frame: Baseline
The primary analysis will be an investigation regarding the athletic adaptation using resting ECG
Time frame: Baseline
The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: No
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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.
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 Athletes Heart, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2017. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hajnalka Vágó, MD, PhD (+36208258058, vagoha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary analysis will be an investigation regarding the athletic adaptation using CMR (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2017.