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

NCT05771987 | Unknown

• 1 other identifier: 09C826
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical improvement: change in NYHA class

  6-12 months

• Clinical improvement: change in exercise capacity

  6-12 months

• Clinical improvement: change in peak VO2

  6-12 months

• Clinical improvement: change in NT-proBNP concentration

  6-12 months

Study Arms (1)

HCM patients with LVOT obstruction

EXPERIMENTAL

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.

Procedure: pace maker implant guided by acute hemodynamic testing

Interventions

pace maker implant guided by acute hemodynamic testing PROCEDURE

To evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of HOCM to pacing

HCM patients with LVOT obstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Valeria Rella

CONTACT

+393491482967; v.rella@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: June 28, 2018
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)