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

• Status: Withdrawn
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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