Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients (NCT00586794) | Clinical Trial Compass
TerminatedPhase 3
Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients
Germany24 participantsStarted 2007-12
Plain-language summary
Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that constitutes a great burden at the individual as well as the familial and social level. The combination of critically increased pulmonary vascular resistance, progressive pressure load of the right ventricle and disturbance of pulmonary gas exchange result in long-term polymorbidity. The objective of this study is to provide evidence of improvement of patients exercise tolerance as well as general conditions by treatment with oral sildenafil as a specific pulmonary vasodilator.
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. Written informed consent obtained.
✓. No participation in another AMG driven study attendancing this treatment protocol
✓. Age at least 14 years
✓. Presence of cyanosis with \< 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
✓. Clinical indication for the invasive diagnostic procedures planned for the study is given; this is evaluated on the basis of observation before, during and after medicinal therapy)
✓. Presence of PAH as diagnosed by invasive methods with Rp:Rs \> 0.5 measured at rest, before testing of pulmonary vasodilatory reserve
✓. One of the following diagnoses:
✓. non-corrected large congenital shunting defect at atrial, ventricular or arterial level:
Exclusion criteria
✕. pregnancy or lactation
✕
What they're measuring
1
To determine the distance of walking, which is performed during a 6- min walking test; oxygen saturation and relation of resistance Rp : Rs during the examination with "Herzkatheter", described as the difference between visit 1 (baseline) and visit 4
Timeframe: visit 1 and visit 4 (after 26 weeks)
Trial details
NCT IDNCT00586794
SponsorCompetence Network for Congenital Heart Defects
. women of child-bearing age who are sexually active without practising highly effective methods of contraception
✕. any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
✕. substance abuse (alcohol, medicines, drugs)
✕. other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
✕. insufficient compliance
✕. missing willingness to storaging and transferring pseudonymous disease data within this study.
✕. subjects who are not able to perform Cardio-Pulmonary Exercise Testing (CPX).