Cardiac Remodeling, VentricularINFINITENCT03076788
Intracardiac Flow Remodeling in Athletes
An observational study of Cardiac Remodeling, Ventricular, run by University Hospital, Caen at 1 site in France.
Trial summary
The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Remodeling, Ventricular
- What is being tested?
- electrocardiogram and echocardiography
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Jan 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Athletes
Who may be able to join
- Age > 18yrs old
- Ability to give written consent for participating in the study
Who cannot join
- Age < 18yrs old
- Cardiac diseases, arterial hypertension, cardiac devices, diabetes, renal, liver or pulmonary failure
Trial locations and contacts
1 site in 1 country.
About this study
The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. This prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. This study is observational, we do not interfere with athlete's training.
- Conditions
- Cardiac Remodeling, Ventricular
- Being tested
- electrocardiogram and echocardiography
- Keywords
- echocardiography, intraventricular pressure gradients, cardiac remodeling, athletes
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiogram and echocardiographyOther
We retrieved all electrocardiograms and echocardiography made during the clinical examination of each athlete and each sedentary control.
- Standard 12 lead ECG
- Trans-thoracic echocardiography examination of cardiac function, morphology and intracardiac flow.
| Study group | Role | What they receive |
|---|---|---|
| Athletes | Professional and amateur athletes examined during the medical follow-up at the medical sport centre of Caen University Hospital.
The medical examination consists in a clinical exam, an electrocardiogram and an echocardiography. Receives: Other: electrocardiogram and echocardiography | |
| Sedentary controls | Sedentary patients assessed in the cardiology unit with a normal heart function.
The medical examination consists in a clinical exam, an electrocardiogram and an echocardiography. Receives: Other: electrocardiogram and echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ventricular response to exercise training by echocardiography.
- 2D- morphological and functional parameters of both left and right ventricles:
- end-diastolic and end-systolic dimensions (cm)
- left ventricular mass (g)
- ventricular end-diastolic and end-systolic areas (cm²)
- ventricular ejection fraction (%)
- atrial volumes (ml)
- diastolic indices by pulsed wave Doppler and tissue Doppler (cm/s)
- myocardial deformation by speckle tracking (%)
- 3D- morphological and functional parameters of both left and right ventricles:
- ventricular full volumes (ml)
- ejection fraction (%)
- Intracardiac flow measurements by color Doppler M-mode: estimation of intra ventricular pressure gradients between the base and the apex (mmHg).
Measured: Day 1
Secondary outcomes (2)
Evaluation of ventricular response to exercise training by electrocardiogram
- heart rate (bpm),
- ventricular hypertrophy (mV)
- atrial remodeling (mV)
Measured: Day 1
Sport and medical history questionnaire
exercise training program, medical past history, cardiovascular risk factors, treatments, doping.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Remodeling, VentricularStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir HODZIC, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076788
- Sponsor's protocol ID
- 16-022.
- Acronym
- INFINITE
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2017
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracardiac Flow Remodeling in Athletes
- ClinicalTrials.gov ID
- NCT03076788
- Acronym / sponsor ID
- INFINITE / 16-022.
- Conditions
- Cardiac Remodeling, Ventricular
- Keywords
- echocardiography, intraventricular pressure gradients, cardiac remodeling, athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 10 Mar 2017 (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.
The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. This prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. This study is observational, we do not interfere with athlete's training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletes | – | Other: electrocardiogram and echocardiographyProfessional and amateur athletes examined during the medical follow-up at the medical sport centre of Caen University Hospital. The medical examination consists in a clinical exam, an electrocardiogram and an echocardiography. |
| Sedentary controls | – | Other: electrocardiogram and echocardiographySedentary patients assessed in the cardiology unit with a normal heart function. The medical examination consists in a clinical exam, an electrocardiogram and an echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Athletes
Key inclusion criteria (2 listed)
- Age > 18yrs old
- Ability to give written consent for participating in the study
Key exclusion criteria (2 listed)
- Age < 18yrs old
- Cardiac diseases, arterial hypertension, cardiac devices, diabetes, renal, liver or pulmonary failure
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 |
|---|---|---|
| electrocardiogram and echocardiographyWe retrieved all electrocardiograms and echocardiography made during the clinical examination of each athlete and each sedentary control. * Standard 12 lead ECG * Trans-thoracic echocardiography examination of cardiac function, morphology and intracardiac flow. | Other | Athletes, Sedentary controls |
Primary outcome
Evaluation of ventricular response to exercise training by echocardiography.
Time frame: Day 1
1. 2D- morphological and functional parameters of both left and right ventricles: * end-diastolic and end-systolic dimensions (cm) * left ventricular mass (g) * ventricular end-diastolic and end-systolic areas (cm²) * ventricular ejection fraction (%) * atrial volumes (ml) * diastolic indices by pulsed wave Doppler and tissue Doppler (cm/s) * myocardial deformation by speckle tracking (%) 2. 3D- morphological and functional parameters of both left and right ventricles: * ventricular full volumes (ml) * ejection fraction (%) 3. Intracardiac flow measurements by color Doppler M-mode: estimation of intra ventricular pressure gradients between the base and the apex (mmHg).
2 secondary outcomes
Evaluation of ventricular response to exercise training by electrocardiogram
Time frame: Day 1
Sport and medical history questionnaire
Time frame: Day 1
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 13 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Remodeling, Ventricular, run by University Hospital, Caen at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 13 Feb 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 France. 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?
Evaluation of ventricular response to exercise training by echocardiography. (time frame: Day 1). 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 13 Feb 2024.