VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension (SIL-REACT)

Kerckhoff Heart Center

Status and phase

Completed

Phase 4

Conditions

Pulmonary Hypertension Associated With Connective Tissue Disease

Treatments

Drug: Sildenafil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01889966

WS2196851

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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