N/A
N=120
Training-induced Increased Left Ventricular Trabeculation
Athletes Heart · Left Ventricular Hypertrabeculation
Bottom Line
View on ClinicalTrials.gov: NCT02568072 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Thickness of Compacted Myocardial Tissue (cm) — 0.53; 0.56; 0.8; 0.85 cm — p=0.44
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- St George's, University of London
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thickness of Compacted Myocardial Tissue (cm) |
0.53; 0.56; 0.8; 0.85 | 0.44 |
| PRIMARY Thickness of Non-compacted Myocardial Tissue (cm) |
0.65; 0.58; 0.8; 0.8 | 0.71 |
| PRIMARY Myocardial Fractal Dimension |
1.20; 1.19; 1.36; 1.36 | 0.37 |
| SECONDARY Increase in Peak Oxygen Consumption on Cardiopulmonary Exercise Testing After Training |
37.9; 38.4 | — |
Summary
This project will expand on research conducted by the investigators' group, where the investigators have demonstrated increased LV trabeculation, satisfying currently existing criteria for LV Non-Compaction Cardiomyopathy (LVNC), in groups exposed to high cardiac workloads. To the investigators' knowledge, this will be the first prospective study aiming to demonstrate a direct relationship between high levels of exercise and increased LV trabeculation. This study may add weight to the theory that this entity currently described as LVNC, is a morphological epiphenomenon common to many distinct myocardial remodeling processes associated with increased cardiac preload and afterload and may better define normal adaptive increases in LV trabeculation.
Eligibility Criteria
Inclusion Criteria
- Asymptomatic and normotensive sedentary individuals (≤2 hours/week of physical activity) aged 18-35 years
Exclusion Criteria
- Hypertension;
- Previous cardiac history;
- Symptoms suggestive of cardiac disease;
- Use of anabolic steroids;
- Use of performance enhancing drugs;
- Abnormal ECG (As defined by the proposed refined ECG screening criteria for black and white athletes published by the Investigators' group)
- Left ventricular hypertrophy >15 mm in males and >12 mm in females;
- Significant valvular heart disease or intra-cardiac shunt on echocardiography
- Individuals with contraindications to cardiac MRI scanning
- Pregnant or breastfeeding women.
Data sourced from ClinicalTrials.gov (NCT02568072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.