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

K

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Sildenafil
Experimental group
Description:
oral Sildenafil 20 mg three times a day for 90 days
Treatment:
Drug: Sildenafil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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