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

May 6, 2025 updated by: Imperial College London

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Optimum Right Ventricular Pacing On
AV Delay Optimised RV Pacing. Subjects will remain in this arm for 3 months before being crossed-over.
Device: AV Delay Optimised RV Pacing
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.
No Intervention: Optimum Right Ventricular Pacing Off
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient symptoms
Time Frame: 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: 6 months
Change in exercise capacity by 6 Minute Walk Test
6 months
Exercise Capacity
Time Frame: 6 months
Change in exercise capacity by Cardiopulmonary Exercise Testing (MVOT)
6 months
BNP
Time Frame: 6 months
Change in BNP - Brain Natriuretic Peptide (blood test)
6 months
Patient preference of optimum pacing on or pacing off
Time Frame: 6 months
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).
6 months
Patient symptoms
Time Frame: 6 months
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.
6 months
Patient symptoms
Time Frame: 6 months
Patient symptoms via a smartphone daily symptom application
6 months
Echo Parameters
Time Frame: 6 months
Change in LV Ejection Fraction (measured by Simpson's Biplane %)
6 months
Echo Parameters
Time Frame: 6 months
Change in resting and peak exertion LVOT gradients (measured by Echo in mm Hg)
6 months
Pacemaker / ICD Activity Data
Time Frame: 6 months
The pacemaker / device will be interrogated to give us information about participants activity levels (hrs per day)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British Heart Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zachary I Whinnett, MRCP PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21HH7277

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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