VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension (SIL-REACT)
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.
Pulmonary Hypertension Associated With Connective Tissue Disease
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation Study)|
- efficacy of Sildenafil I.V. for vasoreactivity testing [ Time Frame: 1.5 hours ] [ Designated as safety issue: Yes ]Right heart catheterisation with comprehensive hemodynamic measurements (pressures in RA, RV, PA, PCW position; cardiac index (CI) by thermodilution; oxygen saturation in the PA; the same under exercise conditions) is performed. In case of precapillary pulmonary hypertension, Sildenafil is given I.V. and acute tolerability, safety and efficacy on hemodynamic parameters are registrated. Successful vasoreactivity testing is defined by lowering the mean PA pressure by 10 mmHg or more, lowering it below 40 mmHg and maintaining / rising of the CI. Safety is mainly defined by lack of a substantial effect of the study drug on systemic blood pressure.
- clinical efficacy of sildenafil per os predicted by testing it intravenously in the course of oral therapy [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Complete hemodynamic and functional assessment after 90 days of oral Sildenafil therapy (same protocol as before except vasoreactivity testing). Hemodynamic parameters which characterize successful oral therapy are mainly mean PA-pressure (decrease), pulmonary vascular resistance (decrease) and cardiac index (increase) - at rest and exercise.
Functional improvement is further characterized by exercise capacity (cardiopulmonary exercise testing: improvement of V´O2 peak by ≥ 1 ml/min/kg), fall of NTproBNP, improvement of echocardiographic parameters of right ventricular function (TAPSE, S´, RV-FAC).
Evaluation, if positive initial vasoreactivity testing results in successful oral therapy as defined above.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
oral Sildenafil 20 mg three times a day for 90 days
oral Sildenafil 3 x 20 mg for 90 days
|Contact: Andreas J Rieth, MD||+49 (0) email@example.com|
|Contact: Christina Reuschling||+49 (0) 60329962252||C.Reuschling@kerckhoff-forschungs-gmbh.de|
|Kerckhoff Heart Center||Recruiting|
|Bad Nauheim, Germany, 61231|
|Contact: Andreas J Rieth, MD firstname.lastname@example.org|
|Principal Investigator: Andreas J Rieth, MD|
|Sub-Investigator: Veselin Mitrovic, MD Prof.|
|Principal Investigator:||Andreas J Rieth, MD||Kerckhoff Heart Center|