Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation Study)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- efficacy of Sildenafil I.V. for vasoreactivity testing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Sildenafil
oral Sildenafil 20 mg three times a day for 90 days
Intervention: Sildenafil (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- clinical efficacy of sildenafil per os predicted by testing it intravenously in the course of oral therapy(90 days)
Investigators
Dr. Andreas Rieth
Dr. med., senior physician cardiology
Kerckhoff Heart Center