VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension

NCT01889966

Last updated date
Study Location
Kerckhoff Heart Center
Bad Nauheim, , 61231, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension Associated With Connective Tissue Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Pulmonary Hypertension Associated With Connective Tissue DiseaseVasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension
NCT01889966
  1. Bad Nauheim,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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, MDKerckhoff 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