VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension (SIL-REACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Kerckhoff Heart Center
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. Andreas Rieth, Kerckhoff Heart Center
ClinicalTrials.gov Identifier:
NCT01889966
First received: June 9, 2013
Last updated: June 26, 2013
Last verified: June 2013

June 9, 2013
June 26, 2013
April 2013
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01889966 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension
Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation 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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension Associated With Connective Tissue Disease
Drug: Sildenafil
oral Sildenafil 3 x 20 mg for 90 days
Other Names:
  • Revatio
  • CAS15 number 139755-83-2
  • EV Substance code SUB10517MIG
Experimental: Sildenafil
oral Sildenafil 20 mg three times a day for 90 days
Intervention: Drug: Sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Andreas J Rieth, MD +49 (0) 60329962677 a.rieth@kerckhoff-klinik.de
Contact: Christina Reuschling +49 (0) 60329962252 C.Reuschling@kerckhoff-forschungs-gmbh.de
Germany
 
NCT01889966
WS2196851
No
Dr. Andreas Rieth, Kerckhoff Heart Center
Kerckhoff Heart Center
Pfizer
Principal Investigator: Andreas J Rieth, MD Kerckhoff Heart Center
Kerckhoff Heart Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP