VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Hypertension Associated With Connective Tissue Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sildenafil

oral Sildenafil 20 mg three times a day for 90 days

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

oral Sildenafil 3 x 20 mg for 90 days

Interventions

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Sildenafil

oral Sildenafil 3 x 20 mg for 90 days

Intervention Type DRUG

Other Intervention Names

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Revatio CAS15 number 139755-83-2 EV Substance code SUB10517MIG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No