Permanent Pacing for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy. (PACE-OHCM)

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

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

Study Overview

• Status: Recruiting
• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Intervention / Treatment: Procedure: pace maker implant guided by acute hemodynamic testing

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valeria Rella; Phone Number: +393491482967; Email: v.rella@auxologico.it

Study Locations

• Italy
  • Milan, Italy, 20149
    • Recruiting
    • Istituto Auxologico Italiano
    • Contact: Valeria Rella; Phone Number: +393491482967; Email: v.rella@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCM patients with LVOT obstruction; 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; To evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of HOCM to pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 09C826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No