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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. Identifier: NCT01889966
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : April 28, 2015
Information provided by (Responsible Party):
Dr. Andreas Rieth, Kerckhoff Heart Center

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Associated With Connective Tissue Disease Drug: Sildenafil Phase 4

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sildenafil
oral Sildenafil 20 mg three times a day for 90 days
Drug: Sildenafil
oral Sildenafil 3 x 20 mg for 90 days
Other Names:
  • Revatio
  • CAS15 number 139755-83-2
  • EV Substance code SUB10517MIG

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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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
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01889966

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Kerckhoff Heart Center
Bad Nauheim, Germany, 61231
Sponsors and Collaborators
Kerckhoff Heart Center
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Principal Investigator: Andreas J Rieth, MD Kerckhoff Heart Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Andreas Rieth, Dr. med., senior physician cardiology, Kerckhoff Heart Center 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
Keywords provided by Dr. Andreas Rieth, Kerckhoff Heart Center:
vasoreactivity testing
precapillary pulmonary hypertension
connective tissue disease
mean pressure in the pulmonary artery 25 mmHg or more
mean pulmonary capillary wedge pressure below 16 mmHg
Additional relevant MeSH terms:
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Hypertension, Pulmonary
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