VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension (SIL-REACT)
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ClinicalTrials.gov Identifier: NCT01889966 |
Recruitment Status :
Completed
First Posted : July 1, 2013
Last Update Posted : April 28, 2015
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Hypertension Associated With Connective Tissue Disease | Drug: Sildenafil | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: Sildenafil
oral Sildenafil 20 mg three times a day for 90 days
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Drug: Sildenafil
oral Sildenafil 3 x 20 mg for 90 days
Other Names:
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- 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.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889966
Germany | |
Kerckhoff Heart Center | |
Bad Nauheim, Germany, 61231 |
Principal Investigator: | Andreas J Rieth, MD | Kerckhoff Heart Center |
Responsible Party: | Dr. Andreas Rieth, Dr. med., senior physician cardiology, Kerckhoff Heart Center |
ClinicalTrials.gov Identifier: | NCT01889966 |
Other Study ID Numbers: |
WS2196851 |
First Posted: | July 1, 2013 Key Record Dates |
Last Update Posted: | April 28, 2015 |
Last Verified: | April 2015 |
vasoreactivity testing Sildenafil precapillary pulmonary hypertension |
connective tissue disease mean pressure in the pulmonary artery 25 mmHg or more mean pulmonary capillary wedge pressure below 16 mmHg |
Hypertension, Pulmonary Hypertension Connective Tissue Diseases Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
Sildenafil Citrate Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |