Therapy Refractory Myocardial IschemiaSYDNEYNCT01406535
Improvement of Myocardial Blood Flow by PhosphoDiesterase 5 Inhibition in Coronary Artery Disease
A study testing Vardenafil in people with Therapy Refractory Myocardial Ischemia and Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5 inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with therapy refractory myocardial ischemia due to coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapy Refractory Myocardial Ischemia, Coronary Artery Disease, Unsuitable for Surgical or Percutaneous Revascularisation
- What is being tested?
- Vardenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Stable angina pectoris
- Evidence for myocardial ischemia according to the presence of one or more of the followings:
- Typical angina during exercise test or
- Significant reversible perfusion defects on dipyridamole myocardial radionuclide study
- Coronary artery disease of at least one large epicardial coronary artery with ≥70% stenosis remaining from which new collaterals/vessels could be supplied
- Coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation ƒdue to extensive atherosclerosis
- Optimized anti-ischemic drug therapy (including beta-blocker therapy with at least 50% target dose)
- Subject must be willing and able to give informed consent Eligible patients must fulfill all 6 inclusion criteria.
Who cannot join
- STEMI or NSTEMI within the past 3 months
- Revascularisation procedures within the last 3 months
- Severely reduced systolic left ventricular function EF < 30%
- Systolic blood pressure <120mmHg
- Chronic renal insufficiency with a serum creatinine >2.5mg/dl
- Diabetes mellitus with proliferative retinopathy
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- Diagnosed or suspected cancer
- Chronic inflammatory disease
- Therapy with nitrates and nicorandil
- Women who are pregnant or lactating
- Patients with a total occluded vessel and reversible perfusion defects at the marginal zone of scare tissue if they have no additional stenosed vessels causing significant reversible perfusion defects.
- Patients with a total occluded vessel and perfusion defect at rest despite evidence of vital myocardium, if they have no additional stenosed vessels causing significant reversible perfusion defects.
- Eligible patients must demonstrate none of the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sustained Improvement of MYocardial Blood Flow by Intermittent PhosphoDiesterase 5 INhibition in REfractory Coronary ArterY Disease Suggests Enhanced Angiogenesis (SYDNEY)
The aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5 inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with therapy refractory myocardial ischemia due to coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation. For proof of efficacy the following tests will be performed at baseline and one day and 4 weeks after discontinuation of therapy: Exercise tolerance will be evaluated by bicycle exercise testing. Blood tests will be performed to evaluate markers of angiogenesis (endothelial progenitor cells, vascular endothelial growth factor, basic fibroblast growth factor). The improvement of myocardial perfusion will be tested functionally as increase of coronary flow reserve by positron emission tomography. Moreover, changes in ventricular function, symptoms and quality of life will be assessed.
Read the detailed description
This study is designed as a randomized, double-blind, placebo controlled monocentric study.
Patients will be randomized to two groups; PDE5 inhibitor (vardenafil) or placebo taken as one tablet twice per day for 15 weeks. The analyses will be performed under blinded conditions by external experts not having any direct contact to the investigators or the patients.
Patients with severe coronary artery disease who are judged to be unsuitable for surgical revascularization because of a bad general state of health or unsuitable for percutaneous revascularization because of the bad morphology of coronary arteries by an expert panel of interventionists and cardiac surgeons are eligible for this study. Eligible patients meeting inclusion criteria will be invited for participation. At the screening visit (Visit -1) demographic data, medical history, and concomitant medication are documented, vital signs are checked, a physical examination, an ECG, and a routine laboratory test is performed. After giving written informed consent for participation in the study, the patient is randomized to one of the two study groups - PDE5 inhibitor (vardenafil) or placebo taken as one pill twice per day for 15 weeks. Within three weeks after this screening visit, baseline efficacy tests are performed. After the last baseline test the study medication is distributed to the patient (Visit 0). During the treatment phase follow-up visits are scheduled after week 1, 3, 6, and 12 (Visit 1-4). Between week 13 and 15 the same efficacy tests as performed at baseline will be repeated. The final visit after the last efficacy test terminates the active study phase at week 15 (Visit 5). During visit 0 to 5 a clinical examination, an ECG, and clinical routine laboratory parameters (blood chemistry, blood cell count, and coagulation parameters) of the patient are performed.
For proof of efficacy the following tests will be performed at baseline and one day and 4 weeks after discontinuation of therapy: Exercise tolerance will be evaluated by bicycle exercise testing. Blood tests will be performed to evaluate markers of angiogenesis (endothelial progenitor cells, vascular endothelial growth factor, basic fibroblast growth factor). The improvement of myocardial perfusion will be tested functionally as increase of coronary flow reserve by positron emission tomography. Moreover, changes in ventricular function, symptoms and quality of life will be assessed.
Endpoints of this study are:
Primary Endpoint:
- Total exercise duration (bicycle exercise testing)
Secondary Endpoints:
- Time to 1mm ST-segment depression (bicycle exercise testing)
- Time to limiting angina (bicycle exercise testing)
- Myocardial blood flow (PET)
- Left ventricular ejection fraction (PET)
- Mean angina frequency per week
- Score Seattle Angina Questionnaire
- Natriuretic peptides
- Conditions
- Therapy Refractory Myocardial Ischemia, Coronary Artery Disease, Unsuitable for Surgical or Percutaneous Revascularisation
- Being tested
- Vardenafil, Placebo
- Keywords
- Phosphodiesterase 5 inhibition, myocardial perfusion, angiogenesis, coronary artery disease, therapy refractory
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VardenafilDrug
5 mg vardenafil per os twice daily
PlaceboOther
5 mg placebo per os twice daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapy Refractory Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406535
- Sponsor's protocol ID
- MUWCard23022011
- Acronym
- SYDNEY
- Status last verified
- Jan 2011
- First submitted
- 29 Jul 2011
- Last updated
- 1 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Improvement of MYocardial Blood Flow by Intermittent PhosphoDiesterase 5 INhibition in REfractory Coronary ArterY Disease Suggests Enhanced Angiogenesis (SYDNEY)
- ClinicalTrials.gov ID
- NCT01406535
- Acronym / sponsor ID
- SYDNEY / MUWCard23022011
- Conditions
- Therapy Refractory Myocardial Ischemia, Coronary Artery Disease, Unsuitable for Surgical or Percutaneous Revascularisation
- Keywords
- Phosphodiesterase 5 inhibition, myocardial perfusion, angiogenesis, coronary artery disease, therapy refractory
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- First posted
- 1 Aug 2011 (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 aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5 inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with therapy refractory myocardial ischemia due to coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation. For proof of efficacy the following tests will be performed at baseline and one day and 4 weeks after discontinuation of therapy: Exercise tolerance will be evaluated by bicycle exercise testing. Blood tests will be performed to evaluate markers of angiogenesis (endothelial progenitor cells, vascular endothelial growth factor, basic fibroblast growth factor). The improvement of myocardial perfusion will be tested functionally as increase of coronary flow reserve by positron emission tomography. Moreover, changes in ventricular function, symptoms and quality of life will be assessed.
Detailed description
This study is designed as a randomized, double-blind, placebo controlled monocentric study.
Patients will be randomized to two groups; PDE5 inhibitor (vardenafil) or placebo taken as one tablet twice per day for 15 weeks. The analyses will be performed under blinded conditions by external experts not having any direct contact to the investigators or the patients.
Patients with severe coronary artery disease who are judged to be unsuitable for surgical revascularization because of a bad general state of health or unsuitable for percutaneous revascularization because of the bad morphology of coronary arteries by an expert panel of interventionists and cardiac surgeons are eligible for this study. Eligible patients meeting inclusion criteria will be invited for participation. At the screening visit (Visit -1) demographic data, medical history, and concomitant medication are documented, vital signs are checked, a physical examination, an ECG, and a routine laboratory test is performed. After giving written informed consent for participation in the study, the patient is randomized to one of the two study groups - PDE5 inhibitor (vardenafil) or placebo taken as one pill twice per day for 15 weeks. Within three weeks after this screening visit, baseline efficacy tests are performed. After the last baseline test the study medication is distributed to the patient (Visit 0). During the treatment phase follow-up visits are scheduled after week 1, 3, 6, and 12 (Visit 1-4). Between week 13 and 15 the same efficacy tests as performed at baseline will be repeated. The final visit after the last efficacy test terminates the active study phase at week 15 (Visit 5). During visit 0 to 5 a clinical examination, an ECG, and clinical routine laboratory parameters (blood chemistry, blood cell count, and coagulation parameters) of the patient are performed.
For proof of efficacy the following tests will be performed at baseline and one day and 4 weeks after discontinuation of therapy: Exercise tolerance will be evaluated by bicycle exercise testing. Blood tests will be performed to evaluate markers of angiogenesis (endothelial progenitor cells, vascular endothelial growth factor, basic fibroblast growth factor). The improvement of myocardial perfusion will be tested functionally as increase of coronary flow reserve by positron emission tomography. Moreover, changes in ventricular function, symptoms and quality of life will be assessed.
Endpoints of this study are:
Primary Endpoint:
- Total exercise duration (bicycle exercise testing)
Secondary Endpoints:
- Time to 1mm ST-segment depression (bicycle exercise testing)
- Time to limiting angina (bicycle exercise testing)
- Myocardial blood flow (PET)
- Left ventricular ejection fraction (PET)
- Mean angina frequency per week
- Score Seattle Angina Questionnaire
- Natriuretic peptides
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Stable angina pectoris
- Evidence for myocardial ischemia according to the presence of one or more of the followings:
- Typical angina during exercise test or
- Significant reversible perfusion defects on dipyridamole myocardial radionuclide study
- Coronary artery disease of at least one large epicardial coronary artery with ≥70% stenosis remaining from which new collaterals/vessels could be supplied
Key exclusion criteria (13 listed)
- STEMI or NSTEMI within the past 3 months
- Revascularisation procedures within the last 3 months
- Severely reduced systolic left ventricular function EF < 30%
- Systolic blood pressure <120mmHg
- Chronic renal insufficiency with a serum creatinine >2.5mg/dl
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 |
|---|---|---|
| Vardenafil5 mg vardenafil per os twice daily | Drug | – |
| Placebo5 mg placebo per os twice daily | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vardenafil in people with Therapy Refractory Myocardial Ischemia and Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 Aug 2011. 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 Austria. 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.
Are results available for this study?
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.
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 1 Aug 2011.