Eisenmenger SyndromePhase 3NCT00303004
Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
A Phase 3 study testing Bosentan and Sildenafil in people with Eisenmenger Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eisenmenger Syndrome
- What is being tested?
- Bosentan and Sildenafil
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2006to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eisenmenger syndrome
- Negative pregnancy test
Who cannot join
- 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
Show all 9Show fewer
- inherited degenerative diseases in retina
- Breast feeding
- Suspicion of risc of noncompliance.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.
Read the 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.
- Conditions
- Eisenmenger Syndrome
- Being tested
- Bosentan and Sildenafil
- Medical subject headings
- Eisenmenger Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bosentan and SildenafilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking distance
Secondary outcomes (13)
Pulmonary blood flow
Systemic blood flow
Pulmonary resistance
Shunt ratio
Erythropoitin
BNP
Saturation in rest
Saturation in activity
Quality of life
Right ventricle systolic and diastolic function
Working capacity
Oxygen consumption at rest
Oxygen consumption during maximal work
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eisenmenger SyndromeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Lars Soendergaard, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303004
- Sponsor's protocol ID
- 01000
- Status last verified
- Jan 2008
- First submitted
- 14 Mar 2006
- Last updated
- 24 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Iversen K, Jensen AS, Jensen TV, Vejlstrup NG, Sondergaard L. Combination therapy with bosentan and sildenafil in Eisenmenger syndrome: a randomized, placebo-controlled, double-blinded trial. Eur Heart J. 2010 May;31(9):1124-31. doi: 10.1093/eurheartj/ehq011. Epub 2010 Mar 3.
PubMed 20202971
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
- ClinicalTrials.gov ID
- NCT00303004
- Acronym / sponsor ID
- 01000
- Conditions
- Eisenmenger Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eisenmenger syndrome
- Negative pregnancy test
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bosentan and Sildenafil | Drug | – |
Primary outcome
6 minutes walking distance
13 secondary outcomes
Pulmonary blood flow
Systemic blood flow
Pulmonary resistance
Shunt ratio
Erythropoitin
BNP
Saturation in rest
Saturation in activity
Quality of life
Right ventricle systolic and diastolic function
Working capacity
Oxygen consumption at rest
Oxygen consumption during maximal work
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2008.
- Derived from this study: PubMed 20202971Iversen K, Jensen AS, Jensen TV, Vejlstrup NG, Sondergaard L. Combination therapy with bosentan and sildenafil in Eisenmenger syndrome: a randomized, placebo-controlled, double-blinded trial. Eur Heart J. 2010 May;31(9):1124-31. doi: 10.1093/eurheartj/ehq011. Epub 2010 Mar 3.
Related trials for Eisenmenger Syndrome
Not yet recruitingPhase 2
Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome
Congenital Heart Disease (CHD), Eisenmenger Syndrome
RecruitingPhase 4
A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy
Eisenmenger Syndrome, Pulmonary Arterial Hypertension of Congenital Heart Disease
RecruitingObservational study
COMPERA / COMPERA-KIDS
Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Soendergaard, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bosentan and Sildenafil in people with Eisenmenger Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking distance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00303004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2008.