VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary hypertension it is approved for treatment. The trial seeks to find out, whether the acute response to this treatment (= vasoreactivity testing) given intravenously is effective and allows prediction of therapy success during a following oral treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kerckhoff Heart Center
• Collaborator: Pfizer
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Precapillary pulmonary hypertension associated with connective tissue disease

• resting mean pressure in the pulmonary artery of > 24 mmHg

• resting mean pulmonary capillary wedge pressure (PCWP) of < 16 mmHg

• age 18 to 80 years

• women of childbearing potential must have a negative pregnancy test (ß-HCG in urine) and must use effective methods of contraception

• women must not be breastfeeding

• ability to understand and sign the informed consent, correctly signed informed consent

Exclusion Criteria:

• pretreatment with Sildenafil

• contraindications for Sildenafil treatment:

• known intolerance to Sildenafil,

• optic neuropathy (NAION),

• known hereditary retina disease,

• need of nitrate therapy

• advanced liver cirrhosis - CHILD C

• severely reduced renal function with GFR < 30 ml/min/1,73 m²

• stroke or myocardial infarction within the last 6 months