VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension (SIL-REACT)
|ClinicalTrials.gov Identifier: NCT01889966|
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : April 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Associated With Connective Tissue Disease||Drug: Sildenafil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation Study)|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
oral Sildenafil 20 mg three times a day for 90 days
oral Sildenafil 3 x 20 mg for 90 days
- efficacy of Sildenafil I.V. for vasoreactivity testing [ Time Frame: 1.5 hours ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889966
|Kerckhoff Heart Center|
|Bad Nauheim, Germany, 61231|
|Principal Investigator:||Andreas J Rieth, MD||Kerckhoff Heart Center|