- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00303004
Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).
Several clinical trials have shown that there is a beneficial effect of treating patients with primary pulmonary arterial hypertension with Bosentan or Sildenafil and that a combination of these may have an additive or even synergistic effect. No clinical trials with Sildenafil and Bosentan has been conducted for patients with Eisenmengers syndrome. Observational studies and case stories indicate however that the effect of Bosentan or Sildenafil in patients with Eisenmengers syndrome may be as promising in these patients as in patients with primary pulmonary arterial hypertension.
We would like to examine the effect of treating patients with Eisenmengers Syndrome with a combination of Bosentan and Sildenafil.
The primary end point is change in physical performance measured with six minutes walking test.
Secondary end points is change in saturation, NYHA class, cardiac output (cardiac catheterization and innocor measurement), pulmonary vascular resistance (cardiac catheterization) shunt ratio (MRI), strain of right ventricle (BNP and echocardiography), quality of life and serum erythropoitin.
The trial is designed as a randomized, single centre, placebo controlled, double blind cross over study.
Twenty patients with Eisenmengers syndrome is included. All patients will be treated in three months with Bosentan. There after patients will be randomized to receive either Sildenafil (50 mg tid) or placebo as add on therapy for three month. Hereafter a cross over will be made and patients in combination treatment will receive only their native treatment and vice versa.
Examinations for primary and secondary endpoints will be made at baseline, before cross over and at the end of the study. All up titrating of medication will be performed during admittance. Patients will during the study period be close monitored with registration of adverse advents, physical examination and blood tests.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eisenmenger syndrome
- Negative pregnancy test
Exclusion Criteria:
- Elevated liver enzymes to more than 3´times normal value
- Hypotension (SBP < 90 mmhg).
- Mandatory treatment with nitrates
- Myocardial infarction within 3 months
- Stroke within 3 months
- Known allergy to Bosentan or Sildenafil
- inherited degenerative diseases in retina
- Breast feeding
- Suspicion of risc of noncompliance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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6 minutes walking distance
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Secondary Outcome Measures
Outcome Measure |
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Quality of life
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Pulmonary blood flow
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Systemic blood flow
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Pulmonary resistance
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Shunt ratio
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Erythropoitin
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BNP
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Saturation in rest
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Saturation in activity
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Right ventricle systolic and diastolic function
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Working capacity
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Oxygen consumption at rest
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Oxygen consumption during maximal work
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lars Soendergaard, MD, Rigshospitalet, Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Disease
- Congenital Abnormalities
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Syndrome
- Eisenmenger Complex
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Endothelin Receptor Antagonists
- Sildenafil Citrate
- Bosentan
Other Study ID Numbers
- 01000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eisenmenger Syndrome
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Govind Ballabh Pant HospitalCompleted
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Rigshospitalet, DenmarkRikshospitalet University Hospital; Actelion; Lund University Hospital; Hospital...Unknown
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Children's Healthcare of AtlantaCompleted
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University of Sao Paulo General HospitalInCor Heart InstituteRecruitingEisenmenger SyndromeBrazil
-
Gachon University Gil Medical CenterCompletedEisenmenger's Syndrome
-
University of California, Los AngelesCompletedEisenmenger SyndromeUnited States
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Competence Network for Congenital Heart DefectsGerman Federal Ministry of Education and Research; ActelionCompleted
-
University of California, Los AngelesActelionTerminatedPulmonary Arterial Hypertension | Congenital Heart Disease | Eisenmenger's SyndromeUnited States
-
Heidelberg UniversityRecruitingPulmonary Arterial Hypertension | Eisenmenger SyndromeGermany
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ActelionTerminatedPulmonary Arterial HypertensionChina, Malaysia, United States, Austria, Bulgaria, Chile, France, Germany, Greece, Mexico, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, United Kingdom, Vietnam
Clinical Trials on Bosentan and Sildenafil
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Postgraduate Institute of Medical Education and...UnknownAssociated Pulmonary Arterial HypertensionIndia
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Center for Advancing...RecruitingPediatric Pulmonary HypertensionUnited States, Canada
-
Shandong UniversityWest China Second University HospitalNot yet recruitingPersistent Pulmonary Hypertension of the NewbornChina
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University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São Paulo; Instituto do CoracaoCompletedPulmonary Arterial Hypertension | Congenital Heart DiseaseBrazil
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All India Institute of Medical Sciences, New DelhiUnknownPulmonary Hypertension Secondary to Lung Disease and/or HypoxiaIndia
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ActelionCompletedPulmonary Arterial HypertensionUnited States
-
Amsterdam UMC, location VUmcUnknownPulmonary Arterial HypertensionNetherlands
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University of Mississippi Medical CenterTerminatedVascular Function | Racial DisparityUnited States
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ActelionCompletedDigital UlcersFrance, United Kingdom, United States, Austria, Canada, Germany, Italy, Switzerland
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GeropharmCompletedBioequivalenceRussian Federation