Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery

NCT01184404 | Unknown

• 1 other identifier: 03603
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with and without congenital heart disease (CHD). However, cardiac surgery involves many risks of complications, such as bleeding, arrhythmias, and death.Right ventricular failure is another complication, contributing to poor clinical outcome. Right ventricular failure is a clinical syndrome, often difficult to treat, characterized by edema, elevated jugular venous pressure, oliguria, hypotension, and in severe cases shock, multi organ failure and death. Patients with CHD and patients with mitral valve lesions are suspected to be at increased risk for developing right ventricular failure post-operatively. In addition, other clinical factors contributing to right ventricular failure are mechanical pulmonary ventilation, pulmonary hypertension and cardiac surgery. Right ventricular failure during cardiac surgery is caused by the cardiopulmonary bypass by reperfusion with high partial pressures of oxygen, air embolism, and the release of cytokines. The endothelin-1 cytokine induces vasoconstriction of the pulmonary arterioles resulting in right ventricular afterload elevation. Treating patients with an endothelin-1 receptor antagonist might improve clinical outcome post operatively by decreasing right ventricular afterload

Conditions

Congenital Heart Disease

Keywords

Congenital heart disease; Cardiac surgery; Bosentan

Outcome Measures

Primary Outcomes (1)

• peak V'O2

  The primary objective of this study is to determine changes in aerobic capacity (peak V'O2)in adult CHD patients or with mitral valve lesions who undergo surgery comparing treated with non-treated patients.

  18 weeks

Secondary Outcomes (1)

• Right ventricular function

  18 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

The treatment group receives a starting dose of 62.5 mg tablet bosentan twice daily for four weeks followed by 125 mg tablet of bosentan twice daily two weeks prior to and 12 weeks after surgery.

Drug: Bosentan

Control

NO INTERVENTION

Interventions

Bosentan DRUG

The treatment group receives a starting dose of 62.5 mg tablet bosentan twice daily for four weeks followed by 125 mg tablet of bosentan twice daily two weeks prior to and 12 weeks after surgery.

Also known as: Tracleer Bosentan

Treatment

Eligibility Criteria

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

You may qualify if:

• Adults with CHD or mitral valve lesions who are scheduled for elective cardiac surgery

You may not qualify if:

• Current treatment with bosentan
• Systemic arterial pressure \< 85 mmHg
• Incapable of giving informed consent
• Hypersensitivity to bosentan or any of its help substances
• Moderate to severe liver disease: Child-Pugh class B or C
• Raised plasma transaminases level \> three times limiting value.
• Simultaneous use of cyclosporine A
• Percutaneous Transluminal Angioplasty procedures

Sponsors & Collaborators

• Berto J Bouma: lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mark Schuuring, MD

CONTACT

31205668687; m.j.schuuring@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 19, 2010
• Study Start: September 1, 2011
• Primary Completion: July 1, 2016
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

NL (1)