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Status unknownNCT04339582Updated Apr 10, 2020

GENETIC BASIS of LEFT VENTRICULAR APICAL HYPOPLASIA

An observational study in Left Ventricular Apical Hypoplasia (LVAH), New Rare Condition, sponsored by Monaldi Hospital. Status unknown at 1 site in Italy. Open to participants aged Up to 90 Years. Per ClinicalTrials.gov, last updated 2020-04-10.

Sponsored by Monaldi Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
Up to 90 Years
Sex
All
01

Study summary

Brief summary Left ventricular apical hypoplasia (LVAH) is a rare cardiomyopathy characterized by a spherical, truncated LV with some degree of systolic dysfunction, an elongated, normally functioning right ventricle that wraps around the distal left ventricle, deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex and origin of the papillary muscle in the flattened anterior apex. This condition presents with different clinical presentation, ranging from no symptoms to congestive heart failure or malignant tachycardia. The etiology of this condition is currently unknown. The aim of this study is to evaluate the clinical and genetic characteristics of patients with LVAH.

Background Left ventricular apical hypoplasia (LVAH) is described as congenital heart disease with an unusual type of cardiomyopathy that was first described in 2004 by Fernandez-Valls et al. It is an extremely rare disease; to date, only more than twenty cases were described.

The typical imaging features of this cardiomyopathy include: a spherical, truncated LV with some degree of systolic dysfunction; an elongated, normally functioning right ventricle that wraps around the distal left ventricle; deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex; origin of the papillary muscle in the flattened anterior apex. A 2D echocardiogram and cardiac MRI can successfully indicate different morphological features This rare phenomenon frequently presents with different clinical manifestations according to the age of the disease, from no symptoms in children to congestive heart failure, pulmonary edema, or even malignant tachycardia in adults. Congenital or genetical etiology was proposed to explain the development of this rare cardiomyopathy.

The aim of this study is to evaluate the clinical and genetic characteristics of patients with LVAH.

Methods Study population

The study population is composed by consecutive patients with diagnosis of LVAH. Diagnosis of LVAH is based on echocardiographic or cardiac magnetic resonance (CMR) evidence of all the following diagnostic criteria:

  • a spherical, truncated LV with some degree of systolic dysfunction;
  • an elongated, normally functioning right ventricle that wraps around the distal left ventricle;
  • deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex;
  • origin of the papillary muscle in the flattened anterior apex. Patients enrolled followed a common protocol designed by GL (Monaldi Hospital, AORN Colli, University of Campania "Luigi Vanvitelli"). The study protocol was approved, and written informed consent was obtained from each subject, according to the procedure established by the Ethic Committee of our institution.

Study protocol Patients enrolled underwent a comprehensive clinical-genetic evaluation commonly practiced in our cardiology division. In particular, the basal evaluation, consisted family and personal history, physical examination, blood tests, 12-lead electrocardiogram (ECG) at rest, conventional M-mode, two-dimensional and Doppler echocardiography, 24-hour Holter ECG, and cardiac magnetic resonance (CMR), and genetic testing with whole exome sequencing (WES). Moreover, all patients are clinically revaluated every 6-12 months.

02

Conditions studied

  • Left Ventricular Apical Hypoplasia (LVAH), New Rare Condition

Keywords

  • Left ventricular apical hypoplasia (LVAH)
  • Genetic testing
  • Congenital or genetical condition
03

In context

Lead sponsor

Monaldi Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
Up to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population is composed by consecutive patients with diagnosis of LVAH. Diagnosis of LVAH is based on echocardiographic or cardiac magnetic resonance (CMR) evidence of all the following diagnostic criteria:

  • a spherical, truncated LV with some degree of systolic dysfunction;
  • an elongated, normally functioning right ventricle that wraps around the distal left ventricle;
  • deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex;
  • origin of the papillary muscle in the flattened anterior apex. Patients enrolled followed a common protocol designed by GL (Monaldi Hospital, AORN Colli, University of Campania "Luigi Vanvitelli"). The study protocol was approved, and written informed consent was obtained from each subject, according to the procedure established by the Ethic Committee of our institution.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female patients, 0-90 years old, in any distribution.
  • Patients who have the diagnostic criteria for LVAH. Diagnosis of LVAH is based on echocardiographic or cardiac magnetic resonance (CMR) evidence of all the following diagnostic criteria:

    • a spherical, truncated LV with some degree of systolic dysfunction;
    • an elongated, normally functioning right ventricle that wraps around the distal left ventricle;
    • deficiency of the myocardium within the LV apex with adipose tissue infiltrating the apex;
    • origin of the papillary muscle in the flattened anterior apex.

Exclusion criteria

Exclusion Criteria:

  • Involvement with any other ongoing studies.
  • Patients who have diagnosis of other Cardiomyopathies
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. new gene of LVAH

    the principal aim of the study is to identify the new gene of LVAH and to investigate on genetic background of this clinical condition

    Time frame: one year later the completation study

07

Study locations

1 of 1 sites recruiting
  • Ospedale V. Monaldi, Università degli studi della Campania, Luigi Vanvitelli
    Naples, 80121, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2013, a primary completion of Mar 2022 and a completion of Mar 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2020
First posted
Apr 9, 2020
Start
Sep 20, 2013
Primary completionEst.
Mar 2022
CompletionEst.
Mar 2023
Last update
Apr 10, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04339582
Lead sponsor
Monaldi Hospital
Collaborators
Bambino Gesù Hospital and Research Institute
Responsible party
GIUSEPPE LIMONGELLI (Principal Investigator, Monaldi Hospital) — Principal investigator
First posted
Apr 9, 2020
Start date
Sep 20, 2013
Primary completion
Mar 2022 (estimated)
Completion
Mar 2023 (estimated)
Last update
Apr 10, 2020

Study contacts

GIUSEPPE LIMONGELLI, PHD,MD
Contact
limongelligiuseppe@libero.it
3776902779
MARTINA CAIAZZA, BMC
Contact
martina.caiazza@yahoo.it
3391574484

Oversight

Data monitoring committee
Yes
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 Apr 2020. You cannot join it, but the record below documents what was studied.

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