Pacemaker therapy for drug-refractory symptoms in mid-cavity hypertrophic cardiomyopathy

Phase 2

Suspended

• Conditions: Hypertrophic cardiomyopathy; Circulatory System

• Registration Number: ISRCTN82621856
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-11
• Last Update Posted: 4 October 2021
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Direct measurement of obstructive gradient (mmHg) via intracardiac catheter during pacemaker implant; Timepoint(s): During implant

Secondary Outcome Measures

Name	Time	Method
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.