Clinical trial NCT01557582: Assessmet of Patients With PAH Right Ventricular Volume
Official title: Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: IPAH
HPAH
APAH CTD
APAH HIV
APAH PoPH
APAH Drugs/Toxins
APAH CHD repaired
APAH CHD unrepaired
Lead sponsor: VentriPoint Diagnostics Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 103
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial will be defined as positive if the mean VMS-cMRI percent difference is \<10% and \>-10% at a 1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns for the VMS procedure.

Detailed description: The objective of this study is: The comparison of the VMS and MRI values for EDV, ESV, and EF using 75 subjects.

Secondary objectives are:

The determination of VMS inter-observer and intra-observer variability of these quantities using 30 subjects.

Eligibility criteria: Inclusion Criteria:

* Patients with Group 1 Pulmonary Arterial Hypertension
* IPAH
* HPAH
* APAH-CTD
* APAH-HIV
* APAH-PoPH
* APAH-Drugs/Toxins
* APAH-CHD repaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA
* APAH-CHD unrepaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA Patients who can be expected to lie motionless during imagine Males and females 12 years of age and older

Exclusion Criteria:

* Lack of informed consent (and assent as appropriate)
* Other forms of PH not included in inclusion criteria
* Left heart disease including clinically significant valvular disease, ,i.e. moderate or greater mitral regurgitation or stenosis or mild or greater aortic insufficiency or stenosis, pericardial disease, LV systolic dysfunction, i.e. LVEF \<40% or LVSF \<22%, and/or clinically significant LVDD
* Known/detected arrhythmia that interferes with image acquisition
* Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials
* Pregnant or breast-feeding females
* Contraindications for MRI (for those patient that undergo MRI)
* Clinically significant obstructive or restrictive lung disease
* Subjects with known HIV infection who have any clinical or laboratory evidence of any opportunistic pulmonary disease (e.g., tuberculosis, Pneumocystis carinii pneumonia, or other pneumonias)
* PAH associated with thyroid disorders, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy
* Any subjects with congenital heart disease other than the simple congenital to systemic shunts specified in the inclusion criteria
* PAH associated with significant venous or capillary involvement (PCWP ˃ 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
* Clinically significant cardiac ischemic disease
* Systemic hypertension defined as SBP ˃ 160 mmHg and/or DBP ˃ 95 mmHg (treated or untreated)
* Moderate or severe hepatic impairment, i.e., Child-Pugh Class B or C
* Any subject with obstructive sleep apnea or who requires the use of CPAP or BiPAP device

Primary outcomes:
measure: Observed Mean (Std Err) for % Difference Between VMS and MRI.
timeFrame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Secondary outcomes:
measure: Inter-Observer Variability
timeFrame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
measure: Intra-Observer Variability
timeFrame: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor
state: Texas
city: Tononto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Scientific Advisory Board
name: Robyn Barst, MD
role: PRINCIPAL_INVESTIGATOR
References: