Active clinical trials for "Hypertension, Pulmonary"

This is a study to demonstrate the feasibility of an individual dose titration scheme based on the systolic blood pressure with a dose range from 1.0 mg TID to 2.5 mg TID. Patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) will be included. After diagnosis by an expert center, patients receive medication three times a day starting with 1.0 mg TID. The first tablets are given in the hospital, then the patients are allowed to go home and take the medication at home. After 2 weeks, patients return to the hospital for an ambulatory visit and the dose may be increased based on the actual condition of the patient (blood pressure and adverse events). Several measurements will be performed to test the efficacy of the drug and whether there are any unwanted reactions to the drug (blood tests, ECG, 6 minute walk test, imaging by Echo, quality of life scores). The dose of the drug will then be increased further until unwanted effects may occur or the blood pressure drops to low. The highest dose tested will be 2.5 mg TID. After 12 weeks the patient is going to stay in the hospital again and a right heart catheter is performed to examine the changes in hemodynamics after 12 weeks of treatment with the drug. If the patients give their consent they can enter a long-term extension trial continuing on BAY63-2521 with the dose reached after 12 weeks. Every 3 months an ambulatory visit at the specialist center will be performed including measurements of safety (blood tests, ECG, clinical assessment) and efficacy (6 minute walk test, Borg dyspnea scale, NT-pro BNP). Blood tests and ECG have been removed begin of 2013 as safety parameter by amendment 7; furthermore Borg dyspnea score and NT-proBNP have been removed as efficacy parameter. Initially the inclusion of ten patients suffering from chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) was planned. Later on the patient number was amended and 75 patients entered the trial. Furthermore the trial duration was extended and a long term treatment with BAY63-2521 was offered to the patients. Finally 68 patients moved over to the long term extension period of the trial.

Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.

This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).

The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.

Summary of the proposed research: The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been used to cause a decrease not only of the pulmonary but also of the systemic vascular tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary vasodilatation without affecting the systemic blood pressure as shown in preliminary studies/case reports. No large trials exist for this type of use of the drug so far. Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry out a prospective, double blinded, randomized trial to show that the nebulized iloprost decreases pulmonary hypertension selectively and improves oxygenation in ARDS.

The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.

The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).

Post-operative pulmonary hypertension is a risk factor for right ventricular failure and an increasing cause of morbidity and mortality in patients undergoing high-risk cardiac surgery. Several treatments have been used to treat and reduce post operative pulmonary hypertension. Unfortunately none of these treatments are approved for use in this condition and only one (inhaled nitric oxide) is specific enough to pulmonary hypertension to not cause dangerous low blood pressure in the rest of the body. Sadly, inhaled nitric oxide is difficult and expensive to use, and can cause lung damage. Sildenafil citrate is quite specific to the lung vessels, is easy to administer and does not easily cause low blood pressure in other areas of the body. We hypothesize that oral sildenafil 12.5mg will decrease the baseline (pre-dose) mPAP by at least 20% compared with a placebo.

Inhaled nitrous oxide (iNO) will be compared to aerosolized iloprost (ILO) in pediatric patients after cardiac surgery with pulmonary hypertension. The hypothesis is that iloprost is more effective in preventing pulmonary hypertensive crises.