Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT01406535
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
2011-08-01
First Post:
2011-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Myocardial Blood Flow by PhosphoDiesterase 5 Inhibition in Coronary Artery Disease
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Sustained Improvement of MYocardial Blood Flow by Intermittent PhosphoDiesterase 5 INhibition in REfractory Coronary ArterY Disease Suggests Enhanced Angiogenesis (SYDNEY)
Status:
TEMPORARILY_NOT_AVAILABLE
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYDNEY
Brief 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. 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: