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

NCT01812434 | Withdrawn DMC

• 1 other identifier: 1001M76094
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 improve endothelial function, resulting in increased production of nitric oxide, reduced activation of circulating endothelial cells, and increased endothelial progenitor cells.

Conditions

Cardiac Allograft Vasculopathy

Outcome Measures

Primary Outcomes (1)

• Mean change in SAE and in the number of endothelial progenitor cells after 4 weeks of treatment between placebo and sildenafil

  Mean change in SAE after 4 weeks of treatment between placebo and sildenafil and mean change in the number of endothelial progenitor cells after 4 weeks of treatment

  4 weeks

Secondary Outcomes (1)

• Determine variability of SAE and large artery elasticity (LAE) in heart transplant recipients in order to plan a multi-center trial that will use arterial elasticity as a primary outcome

  16 weeks

Study Arms (2)

Sildenafil

EXPERIMENTAL

Patients will be randomized to sildenafil arm taken three times a day for 28 days and then crossed over to the alternate arm.

Drug: Sildenafil

Placebo

EXPERIMENTAL

Subject randomized to either Sildenafil or placebo arm

Drug: Placebo

Interventions

Sildenafil DRUG

20mg three time daily for 28 days

Also known as: Viagra

Sildenafil

Placebo DRUG

20 mg three times daily for 28 days

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Sildenafil Citrate; Sugars

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Study Officials

• Monica M Colvin-Adams, MD.MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: March 18, 2013
• Study Start: October 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)