VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension
NCT01889966
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension | |||
Official Title ICMJE | Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation Study) | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Pulmonary Hypertension Associated With Connective Tissue Disease | |||
Intervention ICMJE | Drug: Sildenafil
oral Sildenafil 3 x 20 mg for 90 days Other Names:
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Study Arms ICMJE | Experimental: Sildenafil
oral Sildenafil 20 mg three times a day for 90 days Intervention: Drug: Sildenafil | |||
Publications * | Rieth AJ, Richter MJ, Berkowitsch A, Frerix M, Tarner IH, Mitrovic V, Hamm CW. Intravenous sildenafil acutely improves hemodynamic response to exercise in patients with connective tissue disease. PLoS One. 2018 Sep 20;13(9):e0203947. doi: 10.1371/journal.pone.0203947. eCollection 2018. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 10 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2015 | |||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01889966 | |||
Other Study ID Numbers ICMJE | WS2196851 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Dr. Andreas Rieth, Kerckhoff Heart Center | |||
Study Sponsor ICMJE | Kerckhoff Heart Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Kerckhoff Heart Center | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |