Clinical trial NCT00483626: Hemodynamic Response After Six Months of Sildenafil
Official title: Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: hemodynamic
pulmonary hypertension
sildenafil
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2007-06-07
Enrollment: 27
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the clinical, functional and hemodynamic response after six months of sildenafil 50 mg TID in patients with pulmonary arterial hypertension.

Detailed description: Pulmonary arterial hypertension is a chronic devastating disease. There are few approval oral treatments. Sildenafil, a phosphodiesterase 5 inhibitors, has been recently approved for patients on functional class II and III showing hemodynamic benefits after 12 weeks of treatment. Long term hemodynamic evaluation after sildenafil treatment has not been evaluating in pulmonary arterial patients on functional class II to IV.

The protocol has been designed to evaluate patients on functional class II to IV from baseline conditions and after 6 months of sildenafil treatment (50 mg po TID). Clinical (functional class), functional (walked distance-6 minute walking test) and Hemodynamic evaluation is planned to be performed at baseline and after 6 months of treatment.

Eligibility criteria: Inclusion Criteria:

* Patients older than 15 years old with Pulmonary arterial hypertension according with WHO hemodynamic definition,
* Who signed informed consent,
* Able to swallow tablets and follow instructions.

Exclusion Criteria:

* Patients with pulmonary hypertension with other categories than pulmonary arterial hypertension (associated to COPD, lund diseases, sleep apnea, thromboembolic disease, hight altitude), patients asymptomatic, patients who were responders to adenosine during hemodynamic test, patients treated with specific treatments for pulmonary arterial hypertension before started the study such as sildenafil, prostanoids, endothelin receptors blockers.

Primary outcomes:
measure: Arterial pulmonary resistance index
timeFrame: 6 months
Secondary outcomes:
measure: Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class.
timeFrame: 6 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: National Instiute of Thorax
state: Metropolitanta
Study officials:
affiliation: National Institute of Thorax
name: Monica M Zagolin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galie N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, Fleming T, Parpia T, Burgess G, Branzi A, Grimminger F, Kurzyna M, Simonneau G; Sildenafil Use in Pulmonary Arterial Hypertension (SUPER) Study Group. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005 Nov 17;353(20):2148-57. doi: 10.1056/NEJMoa050010.