PHASE CONTRAST MAGNETIC RESONANCE (MR) IMAGING IN MONITORING THE EFFECTS OF TADALAFIL IN PATIENTS WITH OUT-OF-PROPORTION PULMONARY HYPERTENSION AND LEFT VENTRICULAR DYSFUNCTION - ND

• Conditions: Pulmonary Hypertension ``out-of-proportion`` associated to moderate left ventricular dysfunction; MedDRA version: 9.1Level: LLTClassification code 10037406

• Registration Number: EUCTR2010-022820-61-IT
• Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-22
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

patients aged > 18 yrs with out-of-proportion hypertension associated to moderate left ventricular dysfunction (a subgroup of the 2? category of the WHO clinical classification system Venice 2003 ervision) NYHA class IIa referred to pulmonary hypertension center for evaluation. - moderate left ventricular dysfunction is defined as left ventricular ejection fraction between 35 and 45% - pulmonary hypertension out-of-proportion associated to left ventricular dysfunction is defined as mean mean pulmonary arterial pressure (PAP = 40-45 mmHg and a transpulmonary pressure gradient (mean PAP- mean pulmonary wedge pressure –PWP) > 12 mmHg (ESC-ERS Guidelines 2009)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria will be idiopatic pulmonary hypertension and pulmonary hypertension secondary to chronic obstructive or restrictive pulmonary disease, recurrent pulmonary embolism, pulmonary venous congestion, acute or chronic inflammatory lung disease, pregnancy or insufficient contraceptive measures, and previous treatment with PDE inhibitors and contraindication to assumption of PDE5i (patients with hepatic or renal insufficiency and known retinal disease) and concomitant use of nitrate. Hypersensitivity to the active substance or to any of the excipients. Acute myocardial infarction within the last 90 days. Severe hypotension (<90/50 mm Hg). Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. Patients with clinically significant aortic and mitral valve disease. Patients with pericardial constriction. Patients with restrictive or congestive cardiomyopathy . Patients with significant left ventricular dysfunction. Patients with life-threatening arrhythmias. Patients with symptomatic coronary artery disease . Patients with uncontrolled hypertension. Pulmonary veno-occlusive disease (PVOD). Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified