Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension
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Purpose
The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.
| Condition | Intervention |
|---|---|
|
Pulmonary Arterial Hypertension |
Drug: sildenafil citrate |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension |
- Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1 [ Time Frame: Baseline, Year 1 ] [ Designated as safety issue: No ]6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
- Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2 [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
- Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3 [ Time Frame: Baseline, Year 3 ] [ Designated as safety issue: No ]6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
- Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4 [ Time Frame: Baseline, Year 4 ] [ Designated as safety issue: No ]6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
- Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.
- Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
- Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
- Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).
- Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]CI: calculated as COsys divided by BSA.
- Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.
- Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4 [ Time Frame: Baseline, Year 1, 2, 3, 4 ] [ Designated as safety issue: No ]Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.
| Enrollment: | 227 |
| Study Start Date: | July 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Sildenafil ≥20mg three times daily
Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH
|
Drug: sildenafil citrate
Sildenafil citrate, 20mg oral tablets, taken at least three times daily
|
Detailed Description:
The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH
Inclusion Criteria:
- Patients must be at least 18 years of age at study index;
- Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization;
- Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation
Exclusion Criteria:
- Patient has known contraindications to sildenafil at study index;
- Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index
Contacts and Locations| Germany | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, 30625 | |
| Ireland | |
| Mater Misericordiae Hospital | |
| Dublin, Ireland, 7 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01365585 History of Changes |
| Other Study ID Numbers: | A1481297 |
| Study First Received: | June 1, 2011 |
| Results First Received: | October 5, 2012 |
| Last Updated: | January 8, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Keywords provided by Pfizer:
|
Pulmonary arterial hypertension sildenafil citrate Revatio |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Citric Acid Sildenafil Anticoagulants Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Cardiovascular Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013