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Status unknownNCT05771987PACE-OHCMUpdated Mar 16, 2023

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

An interventional study of pace maker implant guided by acute hemodynamic testing in Obstructive Hypertrophic Cardiomyopathy, sponsored by Istituto Auxologico Italiano. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 years 8 months after the study started (first participant enrolled Jun 2018, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Obstructive Hypertrophic Cardiomyopathy
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 10 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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

Interventions

  • Procedurepace 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

06

What researchers measure

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

    Time frame: 3 months

Secondary outcomes

  1. Clinical improvement: change in NYHA class

    Improvement of NYHA class

    Time frame: 6-12 months

  2. Clinical improvement: change in exercise capacity

    6-minutes walking test

    Time frame: 6-12 months

  3. Clinical improvement: change in peak VO2

    Improvement in peak VO2

    Time frame: 6-12 months

  4. Clinical improvement: change in NT-proBNP concentration

    Reduction in NT-proBNP concentration

    Time frame: 6-12 months

07

Study locations

1 of 1 sites recruiting
  • Istituto Auxologico Italiano
    Milan, 20149, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05771987
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Mar 16, 2023
Start date
Jun 28, 2018
Primary completion
Jun 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Mar 16, 2023

Study contacts

Valeria Rella
Contact
v.rella@auxologico.it
+393491482967

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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