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

Obstructive Hypertrophic Cardiomyopathy Clinical Trial

— PACE-OHCM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771987
• Other study ID #: 09C826
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Valeria Rella
• Phone: +393491482967
• Email: v.rella[@]auxologico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Procedure:
• pace maker implant guided by acute hemodynamic testing
To evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of HOCM to pacing

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of LVOT pressure gradient	Long-term reduction in LVOT obstruction at rest and/or after Valsalva/Exercise > 30% in patients responding to acute stimulation test	3 months
Secondary	Clinical improvement: change in NYHA class	Improvement of NYHA class	6-12 months
Secondary	Clinical improvement: change in exercise capacity	6-minutes walking test	6-12 months
Secondary	Clinical improvement: change in peak VO2	Improvement in peak VO2	6-12 months
Secondary	Clinical improvement: change in NT-proBNP concentration	Reduction in NT-proBNP concentration	6-12 months