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Pulmonary Hypertension Associated With Connective Tissue Disease | VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension

Pulmonary Hypertension Associated With Connective Tissue Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pulmonary Hypertension Associated With Connective Tissue Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sildenafiloral Sildenafil 3 x 20 mg for 90 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sildenafiloral Sildenafil 20 mg three times a day for 90 days

Study Status

Completed

Start Date: April 2013

Completed Date: January 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: efficacy of Sildenafil I.V. for vasoreactivity testing

Secondary Outcome: clinical efficacy of sildenafil per os predicted by testing it intravenously in the course of oral therapy

Study sponsors, principal investigator, and references

Principal Investigator: Andreas J Rieth, MD

Lead Sponsor: Kerckhoff Heart Center

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT01889966

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