Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users

Completed

• Conditions: Focal Fibrosis
• Interventions: Diagnostic Test: Cardiovascular Magnetic Resonance; Diagnostic Test: Transthoracic echocardiography

• Registration Number: NCT03862235
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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. 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 Timeline

• Study Start: 2015-04-01
• Primary Completion: 2016-04-01
• Study Completion: 2017-04-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-28
• Last Update Submitted: 2019-02-28
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• Smoking;
• Alcohol consumption;
• Use of diuretics and/or antihypertensive medications;
• Liver and kidney disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anabolic androgenic steroids users	Cardiovascular Magnetic Resonance	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).
Anabolic androgenic steroids users	Transthoracic echocardiography	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).
Sedentary control	Transthoracic echocardiography	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).
Anabolic androgenic steroids nonusers	Cardiovascular Magnetic Resonance	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).
Anabolic androgenic steroids nonusers	Transthoracic echocardiography	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).
Sedentary control	Cardiovascular Magnetic Resonance	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).

Primary Outcome Measures

Name	Time	Method
Cardiac T1-mapping	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.

Secondary Outcome Measures

Name	Time	Method
Myocardial Contractility	1 day	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.

Trial Locations

Locations (1)

Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil