Treatment of Pulmonary Hypertension and Sickle Cell Disease with Sildenafil Therapy - Walk PHaSST

• Conditions: Pulmonary hypertension associated with sickle cell disease

• Registration Number: EUCTR2007-000446-12-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Males or females, greater than or equal to 12 years of age and less than or
equal to 70 years of age
2. For female subjects, on a reliable method of birth control or not physically
able to bear children
3. Electrophoretic documentation of sickle cell disease (including, but not
limited to SS, SC, SD, or Sß°/+ thalassemia)
4. At least mild pulmonary hypertension with TRV = 2.7 m/s by
echocardiogram
5. Six minute walk distance of 150-500 m
6. In the opinion of the investigator, ability to complete the protocol scheduled
assessments during the 16 week, double-blind phase
7. Provision of informed consent and, where applicable, assent
8. Subjects with systemic hypertension must be on a stable antihypertensive
regimen for greater than or equal to 90 days and a stable dose for greater than
or equal to 30 days.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Current pregnancy or lactation
2. Any one of the following medical conditions:
• Stroke within the last six weeks
• New diagnosis of pulmonary embolism within the last three months
• History of retinal detachment or retinal hemorrhage in the last 6 months
• Non-arteritic anterior ischemic optic neuropathy (NAION) in one or both eyes
• History of sustained priapism requiring medical or surgical treatment, unless
currently impotent or on transfusion program within the last two years
• Any unstable (chronic or acute) condition that in the opinion of the
investigator will prevent completion of the study
3. Subjects taking nitrate-based vasodilators (including, but not limited to
nicorandil [available in the UK only] ), prostacyclin (inhaled, subcutaneous or
intravenous) or endothelin antagonists. Subjects taking calcium channel
blockers will be allowed to participate provided they are on a stable dose for =
3 months.
4. Left ventricular ejection fraction < 40% or clinically significant ischemic,
valvular or constrictive heart disease: LVEF <40% or SF < 22%
5. Subjects who are in other research studies with investigational drugs, with the
exception of hydroxyurea, unless the other trial has been approved by the
walk-PHaSST Executive Committee for co-participation
6. Acute or chronic impairment (other than dyspnea), limiting the ability to
comply with study requirements (in particular with 6MWT), e.g., angina
pectoris, intermittent claudication, symptomatic hip osteonecrosis
7. Tonsillectomies for sleep apnea within 3 months prior to randomization
8. Active therapy for pulmonary hypertension, including prostacyclin analog,
endothelin-1 antagonists, or PDE-5 inhibitor
9. Protease inhibitor therapy for the treatment of HIV
10. Subjects taking potent CYP3A4 inhibitor therapy (e.g., itraconazole, ritonavir,
ketoconazole)
11. Subjects who are anticoagulated and have proliferative retinopathy (unless
they have had ophthalmologist recommended intervention (e.g., phototherapy)
or have been otherwise cleared by an ophthalmologist to participate in the
study)
12. Subjects with systolic blood pressure greater than or equal to 140 mmHg OR
diastolic blood pressure greater than or equal to 90 mmHg. See Section 9.3.3
for qualifying blood pressure assessment instructions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified