Pacing for Hypertrophic Obstructive Cardiomyopathy

  • STATUS
    Recruiting
  • End date
    Oct 1, 2025
  • participants needed
    60
  • sponsor
    Imperial College London
Updated on 18 April 2022
chest pain
shock
implantable cardioverter defibrillator

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 we will use high precision haemodynamic, echocardiographic and electrical measurement techniques 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.

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. Combing 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 us 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.

Details
Condition Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy
Treatment AV Delay Optimised RV Pacing
Clinical Study IdentifierNCT05257772
SponsorImperial College London
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All patients will have a clinical diagnosis of HOCM with an LVOT gradient of at least 30 mmHg, at rest or provoked
Patients may be either symptomatic or asymptomatic
Patients with 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 Atrial Fibrillation or high grade Atrio-Ventricular Block
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note