Pulmonary Hypertension and Left Heart Failure MedDRA version: 16.1 Level: LLT Classification code 10024106 Term: Left heart failure System Organ Class: 100000004849 MedDRA version: 16.1 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ventavis
Product Name: Ventavis
Product Code: Q4074
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: ILOPROST TROMETAMOL
CAS Number: 78919-13-8
Concentration unit: µg microgram
Sponsors
Thoraxclinic at the University of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female and male patients of any racial origin with left heart insufficiency and secondary Pulmonary Hypertension - Having fulfilled his/her 18th birthday on Visit 1 (Day -7 to -1) of the study - Written informed consent (must be available before enrollment in the trial) - Modified WHO functional class III-IV - Pulmonary Hypertension diagnosed by right heart catheter showing: o Baseline mean pulmonary arterial pressure (mPAP) > 25 mmHg o Baseline pulmonary vascular resistance (PVR) > 230 dyn x s x cm-5 o Baseline transpulmonary gradient (TPG) > 15 mm Hg - Echocardiogram on Visit 1/Day -7 to -1 consistent with secondary PH, specifically evidence of right ventricular hypertrophy or dilation, and absence of mitral valve stenosis - Patients receiving maximal conventional left heart failure therapy including intensified treatment with diuretics and have been stable for at least 2 months before entering the study - Except for diuretics, vasodilators and antihypertensives, medical treatment should not be expected to change during the entire 12-week study period. - Negative pregnancy test (ß-HCG) at the start of the trial and appropriate contraception throughout the study for women with child-bearing potential - Able to understand and sign the Informed Consent Form - Ability of subject to understand character and individual consequences of the clinical trial 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pulmonary Hypertension of any cause other than permitted in the entry criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease based on pulmonary oedema during a previous vasoreactivity test or on abnormal findings compatible with that diagnosis (septal lines or pulmonary edema previously detected at high resolution computer tomography), congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension - Contraindication for right heart catheterization - Severe lung disease: FEV1/FVC 3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN - Hemoglobin concentration of less than 75 % of the lower limit of normal - Systolic blood pressure < 85 mmHg - History or suspicion of inability to cooperate adequately - Pregnancy and lactation - History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Reduction in pulmonary vascular resistance (PVR) at Day 85 versus baseline determined meassured by right heart catheter (RHC);Timepoint(s) of evaluation of this end point: End of study;Main Objective: To assess efficacy and safety of inhaled Iloprost in treatment of naïve patients with left heart failure and pulmonary hypertension (PH), who are on the waiting list for orthotopic heart transplantation. The primary efficacy endpoint will be the change from baseline to week 12/day 85 in Pulmonary Vascular Resistance (PVR).;Secondary Objective: Secondary objectives are preserving quality of life and preventing worsening of any other organ functions induced by Left Heart Failure and Pulmonary Hypertension. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Hemodynamic parameters determined by right heart catheter as cardiac output, cardiac index, PAP, PCWP, RA-pressure - Echographie values (RA-area, RV-area, Tei, TAPSE, PASP) - 6-minute walking distance - Quality of life (QoL: SF-36, CAMPHOR) - Laboratory parameters: Hemoglobin, hematocrit, AST, ALT, Bilirubin, CRP, sodium, creatinin clearance, NTproBNP) - WHO functional class - Need for resucue medication (Borsentan) - Safety parameters;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Germany
Contacts
Public ContactEkkehard Grünig
Centre for Pulmonary Hypertension
Outcome results
None listed