Phosphodiesterase-5 (PDE-5) Inhibition in Heart Transplant Recipients

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Cardiac Allograft Vasculopathy

In brief

Hypothesis 1: Treatment of heart transplant recipients with sildenafil, a PDE-5 inhibitor, will improve small artery elasticity (SAE) when compared to placebo. Hypothesis 2: PDE-5 inhibition will improve endothelial function, resulting in increased production of nitric oxide, reduced activation of circulating endothelial cells, and increased endothelial progenitor cells.

Key facts

Study ID

NCT01812434

Run by

University of Minnesota

People needed

0

Starts

2010-10-01

Expected to finish

2015-03-01

Last updated by the study team

2019-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject provided written informed consent
• Subject is 18 years old or Older
• Subject is a cardiac transplant recipient between 6 months - 5 years prior to week 0

You may not qualify if…

• Multi-organ transplant
• Been re-transplanted
• A contraindication to taking sildenafil
• Currently taking a PDE-5 inhibitor
• Mean arterial pressure < 65 mmHg
• A Left ventricular outflow obstruction
• A history or active retinitis pigmentosa
• Major surgery within 3 months of week 0
• Active infections to exclude are (CMV infection, febrile illness and Bacterial illness) within 3 months of week 0
• Acute rejection (grade 3A or greater) within 3 months of week 0
• Chronic kidney disease stage 4 (GFR<30 mL/min/1.73 m2) or acute renal failure
• Unstable cardiac disease, including myocardial infarction, stroke, or life- threatening arrhythmia within 6 months of week 0

Where it is running

• University of Minnesota Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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