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Contact Information:

Jagdeep S Mohal, MBBS MRCP 02033133000
j.mohal@imperial.ac.uk


Ahran D Arnold, MRCP PhD 02033133000
ahran.arnold@imperial.ac.uk


Study Location:

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Be Part of Research - Trial Details - Electromechanically Optimised Right Ventricular Pacing In Hypertrophic Cardiomyopathy (EMORI-HCM)

Electromechanically Optimised Right Ventricular Pacing In Hypertrophic Cardiomyopathy (EMORI-HCM)

Recruiting

Open to: ALL

Age: 18.0 - 100.0

Medical Conditions

Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Hypertrophic Obstructive Cardiomyopathy (HOCM) is an inherited cardiac condition which causes the heart muscle to become abnormally thick causing obstruction of blood flow in the heart. This causes debilitating symptoms including shortness of breath, blackouts and chest pain. Current treatments are not ideal as the medication is often poorly tolerated or ineffective.

People with HOCM can often have an Implantable Cardioverter Defibrillator (ICD) to shock them out of dangerous arrhythmias. ICD's can also be used as pacemakers and are a promising treatment option, since they can alter the sequence of the heart muscle contraction thereby relieving the obstruction to the blood flow, making it easier for the heart to pump.

The study will recruit patients who already have an ICD/pacemaker or who are scheduled to have an ICD / pacemaker implanted. For patients who are due to have a device implanted high precision haemodynamic, echocardiographic and electrical measurement techniques will be used to assess whether adjusting the position of the pacing lead (at the time of implant) can bring about changes in LVOT gradient and blood pressure. These patients with a new device and also patients who already have a device in situ will then go on to have atrioventricular delay (AV Delay) optimisation so we can assess what the optimum AV delay should be programmed at in order to bring about the most improvement in LVOT gradient and blood pressure.

Patients will then be recruited into a medium term double blinded randomised crossover study. They will have optimum RV pacing settings turned on for 3 months. They will then return and be crossed over and have optimum RV pacing turned off for a further 3 months. The primary outcome will be to see if optimum RV pacing being turned on is effective in improving symptoms and quality of life.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2022 Oct 2025

Publications

"Arnold AD, Howard JP, Chiew K, Kerrigan WJ, de Vere F, Johns HT, Churlilov L, Ahmad Y, Keene D, Shun-Shin MJ, Cole GD, Kanagaratnam P, Sohaib SMA, Varnava A, Francis DP, Whinnett ZI. Right ventricular pacing for hypertrophic obstructive cardiomyopathy: meta-analysis and meta-regression of clinical trials. Eur Heart J Qual Care Clin Outcomes. 2019 Oct 1;5(4):321-333. doi: 10.1093/ehjqcco/qcz006."; "30715300"; "Slade AK, Sadoul N, Shapiro L, Chojnowska L, Simon JP, Saumarez RC, Dodinot B, Camm AJ, McKenna WJ, Aliot E. DDD pacing in hypertrophic cardiomyopathy: a multicentre clinical experience. Heart. 1996 Jan;75(1):44-9. doi: 10.1136/hrt.75.1.44."; "8624871"; "Breithardt G. MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy): cardiac resynchronization therapy towards early management of heart failure. Eur Heart J. 2009 Nov;30(21):2551-3. doi: 10.1093/eurheartj/ehp383. Epub 2009 Sep 22. No abstract available."; "19773224"; "Kyriacou A, Pabari PA, Whinnett ZI, Arri S, Willson K, Baruah R, Stegemann B, Mayet J, Kanagaratnam P, Hughes AD, Francis DP. Fully automatable, reproducible, noninvasive simple plethysmographic optimization: proof of concept and potential for implantability. Pacing Clin Electrophysiol. 2012 Aug;35(8):948-60. doi: 10.1111/j.1540-8159.2012.03435.x. Epub 2012 Jul 2."; "22747698"; "Jurak P, Curila K, Leinveber P, Prinzen FW, Viscor I, Plesinger F, Smisek R, Prochazkova R, Osmancik P, Halamek J, Matejkova M, Lipoldova J, Novak M, Panovsky R, Andrla P, Vondra V, Stros P, Vesela J, Herman D. Novel ultra-high-frequency electrocardiogram tool for the description of the ventricular depolarization pattern before and during cardiac resynchronization. J Cardiovasc Electrophysiol. 2020 Jan;31(1):300-307. doi: 10.1111/jce.14299. Epub 2019 Dec 5."; "31788894"; "Whinnett ZI, Francis DP, Denis A, Willson K, Pascale P, van Geldorp I, De Guillebon M, Ploux S, Ellenbogen K, Haissaguerre M, Ritter P, Bordachar P. Comparison of different invasive hemodynamic methods for AV delay optimization in patients with cardiac resynchronization therapy: implications for clinical trial design and clinical practice. Int J Cardiol. 2013 Oct 3;168(3):2228-37. doi: 10.1016/j.ijcard.2013.01.216. Epub 2013 Mar 5."; "23481908"

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : AV Delay Optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems) and Echo to assess LVOT gradient change.

Intervention Arm Group : Optimum Right Ventricular Pacing On;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • National Heart & Lung Institute, Imperial College London
    London
    W12 0HS

Jagdeep S Mohal, MBBS MRCP 02033133000
j.mohal@imperial.ac.uk


Ahran D Arnold, MRCP PhD 02033133000
ahran.arnold@imperial.ac.uk



The study is sponsored by Imperial College London and is in collaboration with British Heart Foundation.




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Read full details for Trial ID: NCT05257772
Last updated 03 April 2024

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