Improvement of Myocardial Blood Flow by PhosphoDiesterase 5 Inhibition in Coronary Artery Disease

NCT01406535 | Unknown

• 1 other identifier: MUWCard23022011
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Interventions

Vardenafil DRUG

5 mg vardenafil per os twice daily

Placebo OTHER

5 mg placebo per os twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Rudolf Berger, MD

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 1, 2011
• Last Updated: August 1, 2011

Record last verified: 2011-01

Locations

AU (1)