Permanent Pacing for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy.

Not Applicable

Recruiting

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Procedure: pace maker implant guided by acute hemodynamic testing

• Registration Number: NCT05771987
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

The present trial is undertaken as a pilot study on selected patients, to evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of Obstructive Hypertrophic Cardiomyopathy (OHCM) to pacing, in terms of reduction of Left Ventricular Outflow Tract (LVOT) pressure gradient and functional capacity improvement.

The Primary Objective is to demonstrate a long-term reduction in LVOT obstruction at rest and/or after Valsalva/Exercise \> 30% in patients responding to acute stimulation test

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-28
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• unequivocal diagnosis of HCM, on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness >15 mm or > 13 mm in familial HOCM) and non dilated LV in the absence of another cardiac or systemic disease capable of producing the same magnitude of hypertrophy;
• patients in whom coronary disease has been excluded;
• presence of severe refractory symptoms (NYHA class II-IV), as evidenced by moderate-to-severe functional disability resulting from exertional dyspnea or chest pain sufficient to support a desire for alternative treatment modalities, following administration (in standard dosages) of beta-blocker and either disopyramide or verapamil, independently or in association;
• peak instantaneous LV outflow tract gradient > 50 mm Hg (resting or provoked), estimated by continuous wave Doppler;

Exclusion Criteria

• end-stage phase of HCM (unless CRT therapy is considered);
• ejection fraction <50% (unless CRT therapy is considered);
• severe mitral valve disease (+++) not related to systolic anterior movement and/or papillary muscle abnormalities;
• age below 18 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCM patients with LVOT obstruction	pace maker implant guided by acute hemodynamic testing	Patients with obstructive HCM are considered for this study if 1) symptomatic, 2) refractory to optimized medical therapy and 3) not or poorly\* eligible for septal myectomy or with an indication to implant a pacing device (pacemaker or ICD) independent on the ventricular obstruction.

Primary Outcome Measures

Name	Time	Method
Reduction of LVOT pressure gradient	3 months	Long-term reduction in LVOT obstruction at rest and/or after Valsalva/Exercise \> 30% in patients responding to acute stimulation test

Secondary Outcome Measures

Name	Time	Method
Clinical improvement: change in NYHA class	6-12 months	Improvement of NYHA class
Clinical improvement: change in peak VO2	6-12 months	Improvement in peak VO2
Clinical improvement: change in exercise capacity	6-12 months	6-minutes walking test
Clinical improvement: change in NT-proBNP concentration	6-12 months	Reduction in NT-proBNP concentration

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Milan, Italy