Training-induced Increased Left Ventricular Trabeculation

NCT02568072 | Completed Results

• 2 other identifiers: 15.0035FS/15/27/31465
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Left Ventricular Hypertrabeculation; Athletes Heart

Keywords

exercise; cardiac remodelling; left ventricular non-compaction cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• Thickness of Compacted Myocardial Tissue (cm)

  Measured on echocardiography and cardiac magnetic resonance: 1. Echocardiographic measure of compacted myocardial tissue (systole) - Jenni Compacted layer measurement (cm) 2. Cardiac magnetic resonance measure of compacted myocardial tissue (diastole) - Petersen Compacted layer measurement (cm)

  Baseline and 7 months

• Thickness of Non-compacted Myocardial Tissue (cm)

  Measured on echocardiography and cardiac magnetic resonance: 1. Echocardiographic measure of non-compacted myocardial tissue (systole) - Jenni Non-Compacted layer measurement (cm) 2. Cardiac magnetic resonance measure of non-compacted myocardial tissue (diastole) - Petersen Non-Compacted layer measurement (cm)

  Baseline and 7 months

• Myocardial Fractal Dimension

  Measured on cardiac magnetic resonance, dimensionless unit and measure of endomyocardial boarder complexity. The higher the value the greater the endocardial boarder complexity and therefore the more trabeculation. Two measurements were made: 1. Captur et al. Global mean left ventricular fractal dimension 2. Captur et al. Maximum apical fractal dimension These values are between 1 and 2. Binarisation eliminates pixel detail originating from the blood pool. The edge image is covered by a series of grids. The minimum size is set to 2 pixels. The maximum size of the grid series is dictated by the dimensions of the bounding box, referring to the smallest rectangle that encloses the foreground pixels. Through the implementation of this 2D box-counting approach, a fractal output of between 1 and 2 is expected. The log-lot plot (e) produces a good fit using linear regression and yields a gradient equivalent to - FD (1.363).

  Baseline and 7 months

Secondary Outcomes (1)

• Increase in Peak Oxygen Consumption on Cardiopulmonary Exercise Testing After Training

  Baseline and 7 months

Other Outcomes (1)

• Change in NTproBNP Levels

  Baseline and 7 months

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participants running first marathon event in Virgin London Marathon 2016.

You may qualify if:

• \. Asymptomatic and normotensive sedentary individuals (≤2 hours/week of physical activity) aged 18-35 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• St George's, University of London: lead
• St. Bartholomew's Hospital: collaborator
• Cardiac Risk in the Young: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Barts Heart Centre

London, EC1A 7BE, United Kingdom

Location

Related Links

• Participant information website

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples. Urine samples.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr Andrew D'Silva
• Organization: St George's, University of London

adsilva@nhs.net

020 7188 7188

Study Officials

• Sanjay Sharma, MD FRCP FESC

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-07

Locations

GB (1)