Pulmonary Arterial Hypertension (PAH)Phase 3NCT00586794
Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients
A Phase 3 study testing Sildenafil in people with Pulmonary Arterial Hypertension (PAH), run by Competence Network for Congenital Heart Defects at 20 sites in Germany.
Trial summary
Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that constitutes a great burden at the individual as well as the familial and social level. The combination of critically increased pulmonary vascular resistance, progressive pressure load of the right ventricle and disturbance of pulmonary… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 20 sitesGermany
- Study dates
- Dec 2007to Jun 2012
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-specific:
- Written informed consent obtained.
- No participation in another AMG driven study attendancing this treatment protocol
- Specific:
- Age at least 14 years
- Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
Show all 21Show fewer
- Clinical indication for the invasive diagnostic procedures planned for the study is given; this is evaluated on the basis of observation before, during and after medicinal therapy)
- Presence of PAH as diagnosed by invasive methods with Rp:Rs > 0.5 measured at rest, before testing of pulmonary vasodilatory reserve
- One of the following diagnoses:
- non-corrected large congenital shunting defect at atrial, ventricular or arterial level:
- PAPVD
- ASD
- SVD
- VSD
- AVSD
- TAC
- APW
- PDA
- combinations thereof.
- Surgically corrected shunting defect (diagnoses as above) with significant residual defect
- Other diagnoses with univentricular physiology/ hemodynamics.
Who cannot join
- Non-specific:
- pregnancy or lactation
- women of child-bearing age who are sexually active without practising highly effective methods of contraception
- any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
- substance abuse (alcohol, medicines, drugs)
- other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
Show all 61Show fewer
- insufficient compliance
- missing willingness to storaging and transferring pseudonymous disease data within this study.
- subjects who are not able to perform Cardio-Pulmonary Exercise Testing (CPX).
- Specific:
- pulmonary hypertension secondary to any etiology other than those specified in the inclusion criteria
- subjects with known intolerance of NO and iloprost or their constituents
- acute decompensated heart failure within the 7 days before the invasive diagnostic procedure
- clinically significant haemoptysis within the last 6 months
- hemodynamic instability which would represent an unjustifiable risk during testing of pulmonary arterial vasoreagibility
- arterial hypotension (as defined by age-specific values)
- anemia (Hb < 10 g/dl)
- decompensated symptomatic policythemia; (details: 4.2.2. exclusion criteria)
- thrombocytopenia (< 50.000/µl)
- secondary impairment of organic function:
- impairment of renal function (GFR < 30 ml/min/1,73 m2 BSA)
- impairment of hepatic function (ALT and/or AST > 3 x ULN and bilirubin ≥ 2 mg/dl)
- other sources of pulmonary blood flow which prohibit measurement of the blood flow into the lungs and therefore of the pulmonary vascular resistance:
- Glenn
- BT shunt
- significant number of MAPCAs; (details: 4.2.2. exclusion criteria)
- Obstruction of pulmonary blood outflow:
- obstruction of pulmonary venous return
- mitral valve dysfunction
- Left heart diseases:
- aortic or mitral valve disease (more severe than "mild")
- restrictive or congestive cardiomyopathy
- PCWP/LVEDP > 15 mmHg
- symptomatic coronary artery disease
- Significant valvular diseases other than tricuspid or pulmonary regurgitation (these are not exclusion criteria; details: 4.2.2. exclusion criteria).
- Pericardial constriction
- History of stroke, myocardial infarction or life-threatening arrhythmia within the 6 months before screening
- Bronchopulmonary dysplasia (BPD) and other chronic lung diseases
- History of significant pulmonary embolism
- Other relevant diseases (e.g. HIV, diabetes mellitus requiring medical treatment)
- Subjects with trisomy 21 (reproducibility of 6-MWT and CPX doubtful; communication as to side effects and subjective quality of life doubtful)
- all contraindications against the study medication (see also "4.2.3 concomitant medication")
- hypersensitivity against the active ingredients as well as supplementaries
- patients who lost vision on one eye due to a non arteriitic anterior ischaemic neuropathy of the opticus (NAION).
- Prohibited concomitant medication:
- Any medication listed below which has not been discontinued at least 30 days prior to screening. Specific pulmonary vasodilators during cardiac catheterization are allowed.
- Unspecified concomitant medication
- Other significant medication (a.o. chronic intake of systemic immunosuppression as e.g. systemic glucocorticoids, cytostatic drugs, ciclosporin)
- Instable medication (details: 4.2.5 prohibited concomitant medication):
- begin of a new medication regimen within the last 30 days before screening
- change in the dosage of existing medication within the last 7 days before cardiac catheterization
- Existing anti-pulmonary hypertensive medication (in any form) with:
- PDE-5 antagonists (e.g. sildenafil)
- prostanoids (e.g. iloprost, prostacyclin, beraprost) In case the patient is stable and on Bosentan therapy at least for 6 months. Bosentan (Tracleer®) is unprohibited as concomitant medication.
- Other medication with vascular action:
- alpha blockers
- L-arginin (acts through NO axis)
- ritonavir, nicorandil (act through K+ channels)
- Medication that is not compatible with sildenafil or interferes with the metabolism:
- cytochrome P450-CYP2C9 and CYP3A4 inhibitors (e.g. erythromycin/ketoconazole/itraconazole/protease inhibitors)
- any existing medication that, in the opinion of the investigator, may interfere with sildenafil treatment.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Germany20 sites
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, D-32545
Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin
Berlin, State of Berlin, D-13353
Deutsches Herzzentrum Berlin, Abt. angeborener Herzfehler/Kinderkardiologie
Berlin, D-13353
Evangelisches und Johanniter Klinikum Niederrhein gGmbH, Herzzentrum Duisburg
Duisburg, North Rhine-Westphalia, D-47137
Universitätsklinikum Erlangen, Kinderkardiologische Abteilung, Kinder- und Jugendklinik
Erlangen, D-91054
Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie
Freiburg im Breisgau, Baden-Wurttemberg, D-79106
Universitätsklinikum Giessen and Marburg, Zentrum für Kinderheilkunde und Jugendmedizin
Giessen, Hesse, D-35385
Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, D-06120
Medizinische Hochschule Hannover, Abt. für Kardiologie und Angiologie
Hanover, Lower Saxony, D-30625
Medizinische Hochschule Hannover, Klinik für Kinderheilkunde, Pädiatrische Kardiologie und Pädiatrische Intensivmedizin
Hanover, Lower Saxony, D-30625
Klinikum der Universität Heidelberg, Pädiatrische Kardiologie
Heidelberg, Baden-Wurttemberg, D-69120
Medizinische Klinik und Poliklinik, Abteilung Innere Medizin III
Heidelberg, Baden-Wurttemberg, D-69120
Universitätsklinikum des Saarlandes
Homburg/Saar, Saarland, D-66421
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, D-24105
Ludwig-Maximilian-Universität München, Klinikum Großhadern, Abt. Kinderkardiologie und Intensivmedizin
München-Großhadern, Bavaria, D-81377
Deutsches Herzzentrum München
Munich, Bavaria, D-80336
Universitätsklinikum Münster, EMAH-Zentrum
Münster, North Rhine-Westphalia, D-48149
Elisabeth Kinderkrankenhaus, Zentrum für Kinder- und Jugendmedizin
Oldenburg, Lower Saxony, D-26133
Klinikum Stuttgart, Olgahospital, Klinik für Kinderheilkunde und Jugendmedizin, Pädiatrie 3
Stuttgart, Baden-Wurttemberg, D-70176
Universitätsklinikum Tübingen, Klinik für Kinderheilkunde und Jugendmedizin
Tübingen, Baden-Wurttemberg, D-72076
About this study
Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that constitutes a great burden at the individual as well as the familial and social level. The combination of critically increased pulmonary vascular resistance, progressive pressure load of the right ventricle and disturbance of pulmonary gas exchange result in long-term polymorbidity. The objective of this study is to provide evidence of improvement of patients exercise tolerance as well as general conditions by treatment with oral sildenafil as a specific pulmonary vasodilator.
Read the detailed description
Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that constitutes a great burden at the individual as well as the familial and social level. The combination of critically increased pulmonary vascular resistance, progressive pressure load of the right ventricle and disturbance of pulmonary gas exchange result in long-term polymorbidity. While the patient's ability to care for him-/ herself gets lost over time, the financial burden due to the need for medical consultations and hospital stays increases. This is distressing to both the patient and the family. Usually, death results from cardiac decompensation in the presence of gradually increasing pulmonary vascular resistance and hypoxic lesion of organs including the myocardium (Hopkins, AJC 2002).
With a better understanding of the pathophysiology underlying pulmonary hypertension, novel therapeutic approaches have been developed during the past few years. These include a) inhibition of the NO-cGMP-degrading type 5 phosphodiesterase (PDE-5) and b) antagonising the endothelin system (Krum, Curr Opin Investig Drugs 2003). The goal is a dilatation of the abnormally constricted pulmonary arterial vessels by relaxation of the vascular smooth muscle cells with a reversal of pulmonary vascular remodelling (Ghofrani, Pneumologie 2002).
Specific drugs affecting pulmonary vascular resistance have been studied. Intravenous prostacyclin has major disadvantages: high cost, tachyphylaxis, risk of infection and rebound hypertension upon discontinuation. Inhalative pulmonary vasodilators, in particular iloprost, may be effective in primary pulmonary hypertension (Olschewski, Ann Int Med 1996; Hoeper, Pneumologie 2001), but administration is time-consuming, and due to its mode of application its effects are intermittent, lasting only about 75 minutes (Hoeper, JACC 2000). Considering this, oral treatments appear preferable, because of easy administration and, hence, better patient compliance.
Sildenafil (Revatio®) an inhibitor of the phosphodiesterase 5 (PDE-5) was used in many individual cases (Abrams, Schulze-Neick et al, Heart 2000), some acute studies and two long-term studies in humans to reduce the pulmonary vessel resistance. Significant effects on reduction of the pulmonary vessel resistance were demonstrated for the combination with an inhalational prostanoid (Ghofrani et al, Ann Int Med 2002).Good long-term tolerability and effectiveness over a period of two year were demonstrated by this working group.
The objective of this study is to provide evidence of improvement of patients exercise tolerance as well as general conditions by treatment with oral sildenafil as a specific pulmonary vasodilator. The data obtained are supposed to contribute to the development of guidelines for the treatment of Pulmonary Arterial Hypertension (PAH)caused by congenital heart defects.
The hypotheses are:
- Sildenafil heales specific pulmonary vascular damage, which occurs by hypercirculation as quick-acting inhibiting vasoconstriction.
- Through this there will be a reduction of pulmonary vessel resistance and a normalization of pulmonary reagibility in patients with Eisenmenger syndrome.
- Pulmonary blood circulation and so systemic arterial oxygen delivery will increase.
- The patient benefits from this by improving his exercise tolerance as well as general and clinical condition.
These hypotheses will be tested by comparing findings of the following examinations before, during and after the 52 or 78-week treatment with sildenafil: clinical examination, Electrocardiogram (ECG), echocardiography, ergospirometry, Magnetic Resonance Imaging (MRI), cardiac catheterization with pulmonary artery manometry, and laboratory tests.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- Sildenafil, Placebo
- Keywords
- Hypertension, Eisenmenger
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Eisenmenger Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Revatio®
3x per day 20 mg TID
PlaceboDrug
3x per day, 20 mg TID
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Sildenafil |
| B | Placebo comparator | from the 26th weeks on open-label, all patients were treated with Sildenafil Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the distance of walking, which is performed during a 6- min walking test; oxygen saturation and relation of resistance Rp : Rs during the examination with "Herzkatheter", described as the difference between visit 1 (baseline) and visit 4
Measured: visit 1 and visit 4 (after 26 weeks)
Secondary outcomes (4)
To provide normalization of pulmonary vascular function (reagibility and vasoactive mediators) in dependence on duration of the therapy
Measured: 78 weeks
Parameters of MRI and Echo-diagnostic
Measured: 78 weeks
Quality of life (SF-36)
Measured: 78 weeks
Safety and tolerance of the treatment
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Competence Network for Congenital Heart Defects
- Sponsor type
- Other government
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Siegrun Mebus, MD, Principal investigator, German Heart Institute Munich, Competence Network for Congenital Heart DefectsIngram Schulze-Neick, MD, Study chair, Great Ormond Street Hospital for Sick Children,London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586794
- Sponsor's protocol ID
- MP 3.1 Sildenafil
- Status last verified
- Oct 2010
- First submitted
- 21 Dec 2007
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients
- ClinicalTrials.gov ID
- NCT00586794
- Acronym / sponsor ID
- MP 3.1 Sildenafil
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- Hypertension, Eisenmenger
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Competence Network for Congenital Heart DefectsOther government
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Dec 2007
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Jan 2008 (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.
Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that constitutes a great burden at the individual as well as the familial and social level. The combination of critically increased pulmonary vascular resistance, progressive pressure load of the right ventricle and disturbance of pulmonary gas exchange result in long-term polymorbidity. The objective of this study is to provide evidence of improvement of patients exercise tolerance as well as general conditions by treatment with oral sildenafil as a specific pulmonary vasodilator.
Detailed description
Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that constitutes a great burden at the individual as well as the familial and social level. The combination of critically increased pulmonary vascular resistance, progressive pressure load of the right ventricle and disturbance of pulmonary gas exchange result in long-term polymorbidity. While the patient's ability to care for him-/ herself gets lost over time, the financial burden due to the need for medical consultations and hospital stays increases. This is distressing to both the patient and the family. Usually, death results from cardiac decompensation in the presence of gradually increasing pulmonary vascular resistance and hypoxic lesion of organs including the myocardium (Hopkins, AJC 2002).
With a better understanding of the pathophysiology underlying pulmonary hypertension, novel therapeutic approaches have been developed during the past few years. These include a) inhibition of the NO-cGMP-degrading type 5 phosphodiesterase (PDE-5) and b) antagonising the endothelin system (Krum, Curr Opin Investig Drugs 2003). The goal is a dilatation of the abnormally constricted pulmonary arterial vessels by relaxation of the vascular smooth muscle cells with a reversal of pulmonary vascular remodelling (Ghofrani, Pneumologie 2002).
Specific drugs affecting pulmonary vascular resistance have been studied. Intravenous prostacyclin has major disadvantages: high cost, tachyphylaxis, risk of infection and rebound hypertension upon discontinuation. Inhalative pulmonary vasodilators, in particular iloprost, may be effective in primary pulmonary hypertension (Olschewski, Ann Int Med 1996; Hoeper, Pneumologie 2001), but administration is time-consuming, and due to its mode of application its effects are intermittent, lasting only about 75 minutes (Hoeper, JACC 2000). Considering this, oral treatments appear preferable, because of easy administration and, hence, better patient compliance.
Sildenafil (Revatio®) an inhibitor of the phosphodiesterase 5 (PDE-5) was used in many individual cases (Abrams, Schulze-Neick et al, Heart 2000), some acute studies and two long-term studies in humans to reduce the pulmonary vessel resistance. Significant effects on reduction of the pulmonary vessel resistance were demonstrated for the combination with an inhalational prostanoid (Ghofrani et al, Ann Int Med 2002).Good long-term tolerability and effectiveness over a period of two year were demonstrated by this working group.
The objective of this study is to provide evidence of improvement of patients exercise tolerance as well as general conditions by treatment with oral sildenafil as a specific pulmonary vasodilator. The data obtained are supposed to contribute to the development of guidelines for the treatment of Pulmonary Arterial Hypertension (PAH)caused by congenital heart defects.
The hypotheses are:
- Sildenafil heales specific pulmonary vascular damage, which occurs by hypercirculation as quick-acting inhibiting vasoconstriction.
- Through this there will be a reduction of pulmonary vessel resistance and a normalization of pulmonary reagibility in patients with Eisenmenger syndrome.
- Pulmonary blood circulation and so systemic arterial oxygen delivery will increase.
- The patient benefits from this by improving his exercise tolerance as well as general and clinical condition.
These hypotheses will be tested by comparing findings of the following examinations before, during and after the 52 or 78-week treatment with sildenafil: clinical examination, Electrocardiogram (ECG), echocardiography, ergospirometry, Magnetic Resonance Imaging (MRI), cardiac catheterization with pulmonary artery manometry, and laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Sildenafil |
| B | Placebo comparator | Drug: Placebofrom the 26th weeks on open-label, all patients were treated with Sildenafil |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Written informed consent obtained.
- No participation in another AMG driven study attendancing this treatment protocol
- Age at least 14 years
- Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
- Clinical indication for the invasive diagnostic procedures planned for the study is given; this is evaluated on the basis of observation before, during and after medicinal therapy)
Key exclusion criteria (61 listed)
- pregnancy or lactation
- women of child-bearing age who are sexually active without practising highly effective methods of contraception
- any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
- substance abuse (alcohol, medicines, drugs)
- other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
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 |
|---|---|---|
| SildenafilAlso: Revatio®3x per day 20 mg TID | Drug | A |
| Placebo3x per day, 20 mg TID | Drug | B |
Primary outcome
To determine the distance of walking, which is performed during a 6- min walking test; oxygen saturation and relation of resistance Rp : Rs during the examination with "Herzkatheter", described as the difference between visit 1 (baseline) and visit 4
Time frame: visit 1 and visit 4 (after 26 weeks)
4 secondary outcomes
To provide normalization of pulmonary vascular function (reagibility and vasoactive mediators) in dependence on duration of the therapy
Time frame: 78 weeks
Parameters of MRI and Echo-diagnostic
Time frame: 78 weeks
Quality of life (SF-36)
Time frame: 78 weeks
Safety and tolerance of the treatment
Time frame: 78 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
- (Competence Network for Congenital Heart Defects)Link provided by the sponsor.
Related trials for Pulmonary Arterial Hypertension (PAH)
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
RecruitingPhase 4
Sotatercept in Pulmonary Arterial Hypertension
Pulmonary Artery Hypertension
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
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.
Siegrun Mebus, MD principal investigator
German Heart Institute Munich, Competence Network for Congenital Heart Defects
Ingram Schulze-Neick, MD study chair
Great Ormond Street Hospital for Sick Children,London
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil in people with Pulmonary Arterial Hypertension (PAH), run by Competence Network for Congenital Heart Defects at 20 sites in Germany.
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 21 inclusion and 61 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: stopped early, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany. 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
To determine the distance of walking, which is performed during a 6- min walking test; oxygen saturation and relation of resistance Rp : Rs during the examination with "Herzkatheter", described as the difference between visit 1 (baseline) and visit 4 (time frame: visit 1 and visit 4 (after 26 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2012.