NCT01889966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

June 9, 2013

Last Update Submit

April 26, 2015

Conditions

Pulmonary Hypertension Associated With Connective Tissue Disease

Keywords

vasoreactivity testingSildenafilprecapillary pulmonary hypertensionconnective tissue diseasemean pressure in the pulmonary artery 25 mmHg or moremean pulmonary capillary wedge pressure below 16 mmHg

Outcome Measures

Primary Outcomes (1)

  • efficacy of Sildenafil I.V. for vasoreactivity testing

    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.

    1.5 hours

Secondary Outcomes (1)

  • clinical efficacy of sildenafil per os predicted by testing it intravenously in the course of oral therapy

    90 days

Study Arms (1)

Sildenafil

EXPERIMENTAL

oral Sildenafil 20 mg three times a day for 90 days

Drug: Sildenafil

Interventions

SildenafilDRUG

oral Sildenafil 3 x 20 mg for 90 days

Also known as: Revatio, CAS15 number 139755-83-2, EV Substance code SUB10517MIG
Sildenafil

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerckhoff Heart Center

Bad Nauheim, 61231, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30235235DERIVED

MeSH Terms

Conditions

Connective Tissue Diseases

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Andreas J Rieth, MD

    Kerckhoff Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med., senior physician cardiology

Study Record Dates

First Submitted

June 9, 2013

First Posted

July 1, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

DE(1)