Focal FibrosisNCT03862235
Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users
An observational study of Focal Fibrosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Anabolic androgenic steroids (AAS) abuse may have a toxic on myocardium that could lead to cardiac alterations. Clinical cases reported myocardial fibrosis in AAS users. However, recent studies did not find myocardial fibrosis in AAS users using T1-mapping technique. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Focal Fibrosis
- What is being tested?
- Cardiovascular Magnetic Resonance and Transthoracic echocardiography
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2015to 1 Apr 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Anabolic androgenic steroids users and nonusers were recreational weightlifters or amateur bodybuilding athletes who were recruited from gymnasiums. Sedentary control group was recruited from community sample.
Who may be able to join
- Anabolic androgenic steroids users and Anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years;
- Anabolic androgenic steroids users should be self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year;
- All anabolic androgenic steroids users were on a cycle over the course of the study;
- Sedentary control group: sedentary men without cardiovascular disease.
Who cannot join
- Smoking;
- Alcohol consumption;
- Use of diuretics and/or antihypertensive medications;
- Liver and kidney disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-900
About this study
Official title: Decreased Myocardial Native T1 Times and Impaired Myocardial Contractility in Young Anabolic Androgenic Steroids Users
Anabolic androgenic steroids (AAS) abuse may have a toxic on myocardium that could lead to cardiac alterations. Clinical cases reported myocardial fibrosis in AAS users. However, recent studies did not find myocardial fibrosis in AAS users using T1-mapping technique. The aim of this study was to evaluate cardiac structure by cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). We also evaluated the cardiac contractility in AAS users.
Read the detailed description
Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.
Cardiac structure was assessed by LGE, T1-mapping and ECV. Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and echocardiography (speckle tracking)
- Conditions
- Focal Fibrosis
- Being tested
- Cardiovascular Magnetic Resonance, Transthoracic echocardiography
- Keywords
- anabolic steroid, T1-mapping, cardiac structure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic ResonanceDiagnostic test
The patients underwent to CMR examination on a Philips Achieve 1.5 device. Images were acquired coupled to the electrocardiogram and during respiratory pause, in four chambers, short axis and long axis of the left ventricle, in the same exact location in different sequences. A gradient - echo sequence (steady-state free precession) was used to evaluate cardiac function (functional evaluation). We will also evaluate T1 weighted images (T1 -relaxation times) and T2, performed sequentially, through spin-echo pulse (black-blood), triple inversion recovery sequence, for the morphological evaluation
Transthoracic echocardiographyDiagnostic test
The images were collected by the Vivid E9. The patients were submitted to one-dimensional (M-mode), two-dimensional (B-mode), and three-dimensional (three-dimensional) echocardiographic studies. The images obtained were associated with pulsed, continuous and color Doppler.
| Study group | Role | What they receive |
|---|---|---|
| Anabolic androgenic steroids users | This group had been involved in strength training for at least 2 years, self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year. All participants were on a cycle over the course of the study.
Cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking). Receives: Diagnostic Test: Cardiovascular Magnetic Resonance; Diagnostic Test: Transthoracic echocardiography | |
| Anabolic androgenic steroids nonusers | This group had been involved in strength training for at least 2 years and they have never took anabolic androgenic steroids.
Cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking). Receives: Diagnostic Test: Cardiovascular Magnetic Resonance; Diagnostic Test: Transthoracic echocardiography | |
| Sedentary control | This group were sedentary men without cardiovascular disease.
Cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking). Receives: Diagnostic Test: Cardiovascular Magnetic Resonance; Diagnostic Test: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac T1-mapping
For the identification of microscopic interstitial fibrosis and the calculation of extracellular space volume (ECV) were use the T1-mapping technique, which use the Modified Lock-Locker (MOLLI) pulse sequence. It was performed for image acquisition, before contrast injection with 3 short-axis cuts, in order to define the baseline T1 of myocardium. The evaluation of the MOLLI sequence images at 4 different times has the objective of evaluating the recovery of T1 times after contrast injection, which allows, associated with hematocrit, the calculation of myocardial extracellular space that is directly related to fibrosis in validation studies with endomyocardial biopsy.
Measured: 1 day
Secondary outcomes (1)
Myocardial Contractility
To calculate the left ventricular function, the strain values were used. Using the speckle-tracking technique, the value of the global longitudinal strain (GLS) was extracted through the three apical views, later the mean of 17 myocardial segments was calculated. Normal value for GLS was set to -18%, although in the literature there is no standardized value. Circumferential and radial strain values were estimated by short-axis parasternal views.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Apr 2015
- Primary completion1 Apr 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal FibrosisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Maria Janieire de Nazaré Nunes Alves, University of Sao Paulo General Hospital
- Investigators
- Maria Janieire NN Alves, MD, Principal investigator, Heart Institute (InCor), University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862235
- Sponsor's protocol ID
- CMR- AnabolicSteroids
- Status last verified
- Feb 2019
- First submitted
- 27 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Myocardial Native T1 Times and Impaired Myocardial Contractility in Young Anabolic Androgenic Steroids Users
- ClinicalTrials.gov ID
- NCT03862235
- Acronym / sponsor ID
- CMR- AnabolicSteroids
- Conditions
- Focal Fibrosis
- Keywords
- anabolic steroid, T1-mapping, cardiac structure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 5 Mar 2019 (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.
Anabolic androgenic steroids (AAS) abuse may have a toxic on myocardium that could lead to cardiac alterations. Clinical cases reported myocardial fibrosis in AAS users. However, recent studies did not find myocardial fibrosis in AAS users using T1-mapping technique. The aim of this study was to evaluate cardiac structure by cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). We also evaluated the cardiac contractility in AAS users.
Detailed description
Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.
Cardiac structure was assessed by LGE, T1-mapping and ECV. Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and echocardiography (speckle tracking)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anabolic androgenic steroids users | – | Diagnostic Test: Cardiovascular Magnetic Resonance, Diagnostic Test: Transthoracic echocardiographyThis group had been involved in strength training for at least 2 years, self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year. All participants were on a cycle over the course of the study. Cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking). |
| Anabolic androgenic steroids nonusers | – | Diagnostic Test: Cardiovascular Magnetic Resonance, Diagnostic Test: Transthoracic echocardiographyThis group had been involved in strength training for at least 2 years and they have never took anabolic androgenic steroids. Cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking). |
| Sedentary control | – | Diagnostic Test: Cardiovascular Magnetic Resonance, Diagnostic Test: Transthoracic echocardiographyThis group were sedentary men without cardiovascular disease. Cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Anabolic androgenic steroids users and nonusers were recreational weightlifters or amateur bodybuilding athletes who were recruited from gymnasiums. Sedentary control group was recruited from community sample.
Key inclusion criteria (4 listed)
- Anabolic androgenic steroids users and Anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years;
- Anabolic androgenic steroids users should be self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year;
- All anabolic androgenic steroids users were on a cycle over the course of the study;
- Sedentary control group: sedentary men without cardiovascular disease.
Key exclusion criteria (4 listed)
- Smoking;
- Alcohol consumption;
- Use of diuretics and/or antihypertensive medications;
- Liver and kidney 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 |
|---|---|---|
| Cardiovascular Magnetic ResonanceThe patients underwent to CMR examination on a Philips Achieve 1.5 device. Images were acquired coupled to the electrocardiogram and during respiratory pause, in four chambers, short axis and long axis of the left ventricle, in the same exact location in different sequences. A gradient - echo sequence (steady-state free precession) was used to evaluate cardiac function (functional evaluation). We will also evaluate T1 weighted images (T1 -relaxation times) and T2, performed sequentially, through spin-echo pulse (black-blood), triple inversion recovery sequence, for the morphological evaluation | Diagnostic test | Anabolic androgenic steroids nonusers, Anabolic androgenic steroids users, Sedentary control |
| Transthoracic echocardiographyThe images were collected by the Vivid E9. The patients were submitted to one-dimensional (M-mode), two-dimensional (B-mode), and three-dimensional (three-dimensional) echocardiographic studies. The images obtained were associated with pulsed, continuous and color Doppler. | Diagnostic test | Anabolic androgenic steroids nonusers, Anabolic androgenic steroids users, Sedentary control |
Primary outcome
Cardiac T1-mapping
Time frame: 1 day
For the identification of microscopic interstitial fibrosis and the calculation of extracellular space volume (ECV) were use the T1-mapping technique, which use the Modified Lock-Locker (MOLLI) pulse sequence. It was performed for image acquisition, before contrast injection with 3 short-axis cuts, in order to define the baseline T1 of myocardium. The evaluation of the MOLLI sequence images at 4 different times has the objective of evaluating the recovery of T1 times after contrast injection, which allows, associated with hematocrit, the calculation of myocardial extracellular space that is directly related to fibrosis in validation studies with endomyocardial biopsy.
1 secondary outcome
Myocardial Contractility
Time frame: 1 day
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 5 Mar 2019.
- 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.
Maria Janieire NN Alves, MD principal investigator
Heart Institute (InCor), University of Sao Paulo Medical School
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 Focal Fibrosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 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 5 Mar 2019. 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 Brazil. 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?
Cardiac T1-mapping (time frame: 1 day). 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 5 Mar 2019.