The purpose of this study is to determine whether sildenafil improves parameters of vascular
function and blood markers involved in development of heart disease in patients with
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02908490
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Meets 2010 American College of Rheumatology (ACR) classification criteria for diagnosis of RA
Aged 18 years or older
No known history of CVD (see Exclusion Criteria)
At least one traditional CV risk factor (i.e., older age [men ≥45 years, women ≥55 years], obesity [defined as body mass index (BMI) >30 kg/m2], smoking, hypertension, hyperlipidemia, diabetes mellitus, family history of premature [defined as diagnosed at <65 years old] CVD in first-degree relative)
On stable baseline doses of RA medications, defined as no change in dose within past 4 weeks and no anticipated changes over the next 6 months
On no higher than 10 mg per day of prednisone or prednisone-equivalent within past 4 weeks
RA disease duration (from symptom onset) of more than 6 months
Having clinical disease activity index (CDAI) of >2.8 but ≤22 (i.e., either low or moderate disease activity), within 30 days of study enrollment
Aged <18 years
Known personal history of CVD (clinical diagnoses of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, peripheral arterial disease, percutaneous coronary intervention or coronary bypass graft surgery)
Use of high-dose statins (e.g., atorvastatin 40-80 mg/day or rosuvastatin 20-40 mg/day) currently or within past 3 months, or any dose changes of statins or of blood pressure medications that may affect endothelial function (i.e., angiotensin-converting-enzyme [ACE] inhibitors or angiotensin receptor blockers
[ARBs]) within past 3 months. If on statin or an ACE-I or ARB, there should be no anticipated dose changes over the next 6 months.
Persons with intra-cardiac and intra-pulmonary shunts, unstable cardiopulmonary conditions, or anyone on chronic oxygen therapy
Persons taking nitric oxide donors, organic nitrites and nitrates, such as glyceryl trinitrate (nitroglycerin), sodium nitroprusside, amyl nitrite ("poppers")
Severe hepatic impairment (liver function tests >1.5 times upper limit of normal) within past 4 weeks
Severe impairment in renal function (serum creatinine ≥1.5 mg/dL) within past 4 weeks
Hypotension (defined as blood pressure [BP] <90/60)
Hereditary degenerative retinal disorders (including genetic disorders of retinal phosphodiesterases)
Persons already taking (or taken within 3 months) sildenafil or other PDE inhibitors
(i.e., tadalafil, vardenafil)
Persons unable to provide voluntary written informed consent
Severe hypertension (BP >170/110)
Persons with HIV/AIDS
All locations for NCT02908490
United States (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
View full eligibility
Tris trial is registered with FDA with number: NCT02908490. The sponsor of the trial is Kimberly Liang and it is looking for 26 volunteers for the current phase.
Official trial title: Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?
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