Hypertrophic cardiomyopathy Circulatory System
Conditions
Interventions
Patients will be identified in outpatient cardiomyopathy clinics, with initial screening and eligibility assessment made by a researcher. A trained member of the research team will take informed conse
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, >18 years 2. Referred for PPM +/- ICD implantation for either primary prevention of sudden cardiac death or other indications such as heart block or obstructive physiology 3. HCM patients with a mid-cavity gradient of =30 mmHg demonstrated by echocardiography and morphology confirmed by cardiac MRI. Gradient confirmed by cardiac catheterisation 4. All patients should be taking maximum tolerated doses of beta blockers or verapamil with or without disopyramide 5. Symptoms refractory to optimum medical therapy as above, for example breathlessness, chest pain, dizziness, or syncope
Exclusion criteria
Exclusion criteria: 1. Patients with multi-level obstruction, i.e. across the mid-cavity and outflow tract 2. Patients with moderate or severe valvular stenosis or regurgitation due to primary valvular disease 3. Patients with untreated symptomatic coronary disease 4. Patients in atrial fibrillation at the time of implantation 5. Pregnancy 6. Renal failure with eGFR < 20mL/min 7. Any patient not suitable in the clinicians opinion 8. Any patient who is for whatever reason is not expected for more than one year 9. Patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Direct measurement of obstructive gradient (mmHg) via intracardiac catheter during pacemaker implant; Timepoint(s): During implant | — |
Secondary
| Measure | Time frame |
|---|---|
| The feasibility of performing a cross-over study and the associated performance tests and symptomatic assessments in this patient population. The statistical information collected will be used to design a much larger research trial of patient benefit. | — |
Countries
England, United Kingdom
Outcome results
None listed