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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889966
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. Andreas Rieth, Kerckhoff Heart Center

Tracking Information
First Submitted Date  ICMJE June 9, 2013
First Posted Date  ICMJE July 1, 2013
Last Update Posted Date April 28, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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:
  • Revatio
  • CAS15 number 139755-83-2
  • EV Substance code SUB10517MIG
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
 (submitted: June 26, 2013)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Andreas J Rieth, MD Kerckhoff Heart Center
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