Status:
COMPLETED
VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension
Lead Sponsor:
Kerckhoff Heart Center
Collaborating Sponsors:
Pfizer
Conditions:
Pulmonary Hypertension Associated With Connective Tissue Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01889966
Start Date
April 1 2013
End Date
January 1 2015
Last Update
April 28 2015
Active Locations (1)
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1
Kerckhoff Heart Center
Bad Nauheim, Germany, 61231