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Hypertrophic CardiomyopathyEMORI-HCMNCT05257772

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

A study testing AV Delay Optimised RV Pacing in people with Hypertrophic Cardiomyopathy and Hypertrophic Obstructive Cardiomyopathy, run by Imperial College London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
AV Delay Optimised RV Pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
14 Mar 2022to 16 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • National Heart & Lung Institute, Imperial College London

    London, W12 0HS

Other trials in United Kingdom

About this 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.

Read more

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.

Read the detailed description
  1. To test the impact of changing the pacing site and how it affects intra-ventricular delay and the amount of dyssynchrony. At the time of device implant, the RV lead will be positioned temporarily in the RV apex, low septum, high septum, RV free wall and coronary sinus. Non-invasive blood pressure will be measured by a Finometer device and Echo will assess LVOT gradient whilst pacing is turned on at each site. Ultra-high frequency ECG will be used to assess intraventricular dyssynchrony at each site. Haemodynamic measurements will also be made of aortic pressure and flow using a Combowire (with temporary heparinisation) to assess if non-invasively measured beat-by-beat finometer blood pressure are consistent with invasively measured changes in aortic flow. Combining these measurements will further assess the relationship between level of dyssynchrony, blood pressure and LVOT gradient change. The RV lead will then be implanted in a conventional position.
  2. To use high-precision techniques to assess the impact of adjusting the AV Delay and how it affects blood pressure and LVOT gradient change. After patients have had their device implanted \& those patients who already have a device in situ will then undergo an AV optimisation protocol (paced alternations of AV delay will be made from 40ms in 40ms increments up to 200ms / fusion). Non-invasive blood pressure will be measured (using a Finometer) along with LVOT gradient change with Echo at each AV delay and allow to identify the optimum AV Delay that brings about the most benefit in these acute parameters.
  3. To follow patients over a period of 6 months in a double blinded randomised crossover trial. Patients will have active optimum RV pacing for 3 months. After this point they will then be crossed over for a further 3 months to optimum RV pacing off. Patient and assessor will remain blinded throughout. Patients will have the following assessed at baseline, 3 months and then at 6 months:
  • A symptom questionnaire (Kansas City Questionnaire + EQ5D5L Questionnaire). A smart phone symptom application will also record their daily symptoms during the 6 months follow up.
  • A blood test for BNP
  • A 6 Minute Walk Test \& Cardiopulmonary Exercise test (MVOT)
  • An Echo scan
  • Device interrogation

Through simulation of a mixed-effects model to analyse the cross-over design, 60 patients would provide approximately 83% power.

Being tested
AV Delay Optimised RV Pacing
Keywords
Right Ventricular Pacing, Atrio-Ventricular Delay, Dyssynchrony
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AV Delay Optimised RV PacingDevice

    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.

Study groups in NCT05257772
Study groupRoleWhat they receive
Optimum Right Ventricular Pacing OnActive comparatorAV Delay Optimised RV Pacing. Subjects will remain in this arm for 3 months before being crossed-over.
Receives: Device: AV Delay Optimised RV Pacing
Optimum Right Ventricular Pacing OffNo interventionSubjects 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (9)
  1. Exercise Capacity

    Change in exercise capacity by 6 Minute Walk Test

    Measured: 6 months

  2. Exercise Capacity

    Change in exercise capacity by Cardiopulmonary Exercise Testing (MVOT)

    Measured: 6 months

  3. BNP

    Change in BNP - Brain Natriuretic Peptide (blood test)

    Measured: 6 months

  4. Patient preference of optimum pacing on or pacing off

    An exploratory secondary outcome - patients will be asked at the end of the study which 3 month period they preferred (they will not be told during which 3 month period they were paced and not paced when they answer this question).

    Measured: 6 months

  5. Patient symptoms

    Patient symptoms via patient questionnaire - EQ-5D-5L Questionnaire. EQ-5D-5L health states can be summarised using the 5-digit code or represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. Most EQ-5D value sets have been obtained from a standardised valuation exercise, in which a representative sample of the general population in a country/region is asked to place a value on EQ-5D health states.

    Measured: 6 months

  6. Patient symptoms

    Patient symptoms via a smartphone daily symptom application

    Measured: 6 months

  7. Echo Parameters

    Change in LV Ejection Fraction (measured by Simpson's Biplane %)

    Measured: 6 months

  8. Echo Parameters

    Change in resting and peak exertion LVOT gradients (measured by Echo in mm Hg)

    Measured: 6 months

  9. Pacemaker / ICD Activity Data

    The pacemaker / device will be interrogated to give us information about participants activity levels (hrs per day)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start14 Mar 2022
  3. Primary completion16 May 2025 (estimated)
  4. Study completion16 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257772
Sponsor's protocol ID
21HH7277
Acronym
EMORI-HCM
Status last verified
May 2025
First submitted
14 Feb 2022
Last updated
11 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 23481908
  • 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.

    PubMed 40892619

Questions about this trial

What is this clinical trial studying?

A study testing AV Delay Optimised RV Pacing in people with Hypertrophic Cardiomyopathy and Hypertrophic Obstructive Cardiomyopathy, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient symptoms (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05257772, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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