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Sildenafil in Single Ventricle Patients

NCT ID: NCT01169519

Last Updated: 2013-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the single ventricle palliation results in continued long term attrition. Elevated pulmonary vascular resistance and impaired systemic ventricular function are important risk factors for failure of single ventricle palliation.

Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in the pressure overloaded right ventricle.

The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of sildenafil in single ventricle patients following stage II and III surgical palliation.

Detailed Description

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Conditions

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Heart Disease

Keywords

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Hypoplastic left heart syndrome Hypoplastic right heart syndrome Superior cavopulmonary anastomosis Total cavopulmonary anastomosis Children with single ventricle anatomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sildenafil

Pharmacokinetic and hemodynamic evaluation following sildenafil administration

Group Type ACTIVE_COMPARATOR

Sildenafil by injection

Intervention Type DRUG

Sildenafil 0.125mg/kg injection over 20min

Sildenafil by injection

Intervention Type DRUG

Sildenafil 0.25mg/kg injection over 20min

Sildenafil by injection

Intervention Type DRUG

Sildenafil 0.35mg/kg by injection over 20min

Sildenafil by injection

Intervention Type DRUG

Sildenafil 0.45mg/kg by injection over 20min

Interventions

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Sildenafil by injection

Sildenafil 0.125mg/kg injection over 20min

Intervention Type DRUG

Sildenafil by injection

Sildenafil 0.25mg/kg injection over 20min

Intervention Type DRUG

Sildenafil by injection

Sildenafil 0.35mg/kg by injection over 20min

Intervention Type DRUG

Sildenafil by injection

Sildenafil 0.45mg/kg by injection over 20min

Intervention Type DRUG

Other Intervention Names

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Revatio Revatio Revatio Revatio

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 3 months; ≤120 months.
2. History of congenital heart disease with severe hypoplasia of a right or left ventricle.
3. Undergoing cardiac catheterization as part of standard clinical care.
4. Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion Criteria

1. History of serious adverse event related to sildenafil administration.
2. History of sildenafil exposure within 48 hours of the study.
3. Presence of pulmonary venous obstruction.
4. Treatment with organic nitrates or alpha blockade therapy.
5. Contraindication to cardiac catheterization as determined by the attending cardiologist and including:

1. Significant hemodynamic instability.
2. Sepsis.
3. Need for Extra-Corporeal Membrane Oxygenation (ECMO) support.
4. Venous occlusion precluding adequate access.
5. Recent systemic illness.
6. Renal failure defined as serum creatinine \> 2 times higher than the upper limit of normal.
7. Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase \> 3 times higher than the upper limit of normal.
8. Thrombocytopenia defined as a platelet count \< 50 000 cells/µL.
9. Leukopenia defined as white blood cells \< 2500 cells/µL.
Minimum Eligible Age

3 Months

Maximum Eligible Age

120 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin D Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Hill KD, Tunks RD, Barker PC, Benjamin DK Jr, Cohen-Wolkowiez M, Fleming GA, Laughon M, Li JS. Sildenafil exposure and hemodynamic effect after stage II single-ventricle surgery. Pediatr Crit Care Med. 2013 Jul;14(6):593-600. doi: 10.1097/PCC.0b013e31828aa5ee.

Reference Type RESULT
PMID: 23823195 (View on PubMed)

Tunks RD, Barker PC, Benjamin DK Jr, Cohen-Wolkowiez M, Fleming GA, Laughon M, Li JS, Hill KD. Sildenafil exposure and hemodynamic effect after Fontan surgery. Pediatr Crit Care Med. 2014 Jan;15(1):28-34. doi: 10.1097/PCC.0000000000000007.

Reference Type DERIVED
PMID: 24201857 (View on PubMed)

Other Identifiers

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Pro00025220

Identifier Type: -

Identifier Source: org_study_id