The Assessment of Right Ventricular Contractility in Response to Sildenafil

NCT00742014 | Terminated Phase 3

• 1 other identifier: 1000012265
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to examine the effects of Sildenafil, administered during cardiac catheterization, on right ventricular contractility in children with pulmonary arterial hypertension.

Conditions

Hypertension

Keywords

Pulmonary arterial hypertension; Pediatrics; Sildenafil; Catheterization; Right ventricular contractility

Outcome Measures

Primary Outcomes (1)

• Increase (% change) in endsystolic elastance of the right ventricle from baseline (in comparison to change in endsystolic elastance after inhaled NO)

  30 mins after Sildenafil adminsitration

Study Arms (1)

1

EXPERIMENTAL

Drug: Sildenafil

Interventions

Sildenafil DRUG

One oral dose of Sildenafil (0.5 mg/kg) will be administered nia a nasogastric tube

Also known as: Viagra

1

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Significant pulmonary arterial hypertension (mean pulmonary artery pressure \> 25 mm Hg)
• Patients aged 4-18 years
• Routine cardiac catheterization clinically indicated for deciding therapeutic treatment
• Informed assent/consent from patient/parent

You may not qualify if:

• Suprasystemic pulmonary artery pressures
• Evidence of right heart failure
• History of ventricular arrhythmia
• Known vascular access arrhythmia
• Contraindication to Sildenafil
• Concurrent inotropic / PDE administration
• Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves
• No consent/assent
• Pregnancy or unwillingness to comply with contraceptive advice

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Hypertension; Pulmonary Arterial Hypertension

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

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

Study Officials

• Andrew Redington, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 27, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 19, 2021

Record last verified: 2016-04

Locations

CA (1)