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

NCT05257772 | Active Not Recruiting

• 1 other identifier: 21HH7277
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy; Hypertrophic Obstructive Cardiomyopathy

Keywords

Right Ventricular Pacing; Atrio-Ventricular Delay; Dyssynchrony

Outcome Measures

Primary Outcomes (1)

• Patient symptoms

  Patient symptoms via patient questionnaire - Kansas City Cardiomyopathy Questionnaire. All Kansas City Cardiomyopathy Questionnaire scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent

  6 months

Secondary Outcomes (9)

• Exercise Capacity

  6 months

• Exercise Capacity

  6 months

• BNP

  6 months

• Patient preference of optimum pacing on or pacing off

  6 months

• Patient symptoms

  6 months

Study Arms (2)

Optimum Right Ventricular Pacing On

ACTIVE COMPARATOR

AV Delay Optimised RV Pacing. Subjects will remain in this arm for 3 months before being crossed-over.

Device: AV Delay Optimised RV Pacing

Optimum Right Ventricular Pacing Off

NO INTERVENTION

Subjects will remain in this arm for 3 months before being crossed-over. The pacemaker will be programmed to minimum ventricular pacing \& dynamic AV delay will be programmed off.

Interventions

AV Delay Optimised RV Pacing DEVICE

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.

Optimum Right Ventricular Pacing On

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients will have a clinical diagnosis of HOCM with an LVOT gradient of at least 30 mmHg, at rest or provoked.
• Symptomatic patients
• Can have co-existing mid-cavity obstruction.
• HOCM patients referred for Dual Chamber Pacemaker / ICD Implantation.
• Adults willing to take part (ages 18 - 100 years old)
• Able to give consent.

You may not qualify if:

• Unable to give consent
• Children age \< 18 years or adults \> 100 years old
• Pregnant patient
• Patients with persistent Atrial Fibrillation or high grade Atrio-Ventricular Block

Sponsors & Collaborators

• Imperial College London: lead
• British Heart Foundation: collaborator

Study Sites (1)

National Heart & Lung Institute, Imperial College London

London, W12 0HS, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 30715300 BACKGROUND

• 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.

  PMID: 8624871 BACKGROUND

• 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.

  PMID: 19773224 BACKGROUND

• 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.

  PMID: 22747698 BACKGROUND

• 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.

  PMID: 31788894 BACKGROUND

• 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.

  PMID: 23481908 BACKGROUND

• Mohal JS, Whinnett ZI, Mohiddin SA, Malcolmson J, Elliott P, Ormerod JOM, Prasad S, Ware JS, Cooper RM, Tanner MA, Khalique Z, Shah JS, Keene D, Tangkongpanich P, Lewis EC, Sharma C, Reddy RK, Naraen A, Saleh K, Samways JW, Howard JP, Artico J, Kanagaratnam P, Francis DP, Al-Lamee RK, Varnava A, Shun-Shin MJ, Arnold AD. Electromechanically Optimized Right Ventricular Pacing for Obstructive Hypertrophic Cardiomyopathy: The EMORI-HCM Trial. J Am Coll Cardiol. 2026 Jan 20;87(2):124-139. doi: 10.1016/j.jacc.2025.08.050. Epub 2025 Aug 31.

  PMID: 40892619 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Zachary I Whinnett, MRCP PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 25, 2022
• Study Start: March 14, 2022
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

GB (1)