Status:
WITHDRAWN
Phosphodiesterase-5 (PDE-5) Inhibition in Heart Transplant Recipients
Lead Sponsor:
University of Minnesota
Conditions:
Cardiac Allograft Vasculopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 imp...
Detailed Description
Background and Significance In the United States, heart failure is an epidemic affecting 5,700,000 people, of which an estimated 100,000 to 200,000 suffer from end-stage heart failure. Cardiac transpl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01812434
Start Date
October 1 2010
End Date
March 1 2015
Last Update
November 1 2019
Active Locations (1)
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1
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455