Differentiating athletes heart from Dilated cardiomyopathy.
Research type
Research Study
Full title
USING A DEVISED NON-INVASIVE ALGORITHM CAN PHYSIOLOGICAL LEFT VENTRICULAR ENLARGEMENT WITH LOW LEFT VENTRICULAR EJECTION FRACTION BE DIFFERENTIATED FROM PATHOLOGICAL DILATED CARDIOMYOPATHY?
IRAS ID
286757
Contact name
Sarandeep Marwaha
Contact email
Sponsor organisation
St Georges Univeristy of London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a prospective matched comparative study.
Patients with dilated cardiomyopathy and athletes with dilated chamber size and low ejection fraction will be asked to participate in our research study. They will undergo all routine standard of care test such as ECG, echocardiogram, stress echocardiogram, CPET, CMR and routine bloods tests such as FBC, electrolytes, mineral and thyroid levels, autoimmune screen, NT-proBNP.
Athletes with known dilated chamber size with normal ejection fraction will also be recruited as controls. They will undergo their standard of care tests which includes ECG and echocardiogram. They will also be consented for research tests of stress echocardiogram, CPET, and NT-proBNP. CMR will be conducted should further funding be acquired.
All participants will be consented for additional storage of blood to later test for heart biomarkers should further funding be established. If additional funding is not recieved after 1 year, these samples will be disposed of.
Research will take place at St Georges Hospital, Royal Brompton Hospital and Wythenshawe Manchester hospital (linked with Manchester institute of health and performance).
Investigators will enter relevant data from all participants procedures onto a electronic or paper CRF in pesudonymised form and provide the sponsor.
The direct clinical care teams will be made aware of the results of the participants in their care.
It is intended that up 300 patient will be recruited during this study to allow for a 10% drop out rate. As 252 participants are required (76 DCM patients, 76 athletes with dilated LV and 100 athletes with dilated LV and low EF). The sample size is based on statistical calculation.Direct care physicians will use their own discretion to use the results of the investigations conducted to suggest ongoing management/treatments/follow up. No further follow up will be done for research purposes.
REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0628
Date of REC Opinion
31 Aug 2021
REC opinion
Favourable Opinion