Effects of Sildenafil on Signs and SYmptoms of Ischemia, Myocardial BlooD Flow, and Markers of ANgiogenesis in Patients with REfractory CoronarY Artery Disease

Phase 1

Conditions: Patients with coronary artery disease who suffer from myocardial malperfusion and continue to experience angina despite maximal medical and revascularization therapy are called no-option patients.
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-023375-26-AT

Lead Sponsor: Medizinische Universität Wien, Klinik für Innere Medizin II, Abteilung für Kardiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1) Stable angina pectoris
2) 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
3) Coronary artery disease of at least one large epicardial coronary artery with =70% stenosis remaining from which new collaterals/vessels could be supplied
4) Coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation due to extensive atherosclerosis
5) Optimized anti-ischemic drug therapy (including beta-blocker therapy with at least 50% target dose)
6) Subject must be willing and able to give informed consent
Eligible patients must fulfil all 6 inclusion criteria.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1)STEMI or NSTEMI within the past 3 months
2)Revascularisation procedures within the last 3 months
3)Severely reduced systolic left ventricular function EF < 30%
4)Systolic blood pressure <120mmHg
5)Chronic renal insufficiency with a serum creatinine >2.5mg/dl
6)Diabetes mellitus with proliferative retinopathy
7)Diagnosed or suspected cancer
8)Chronic inflammatory disease
9)Therapy with nitrates and nicorandil
10)Women who are pregnant or lactating
11) 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.
12) 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Primary Endpoint:<br>-Total exercise duration (bicycle exercise testing)<br>;Timepoint(s) of evaluation of this end point: baseline<br>after 12 weeks of treatment<br>4 weeks after end of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary Endpoints:<br>-Time to 1mm ST-segment depression (bicycle exercise testing)<br>-Time to limiting angina (bicycle exercise testing)<br>-Myocardial blood flow (PET) <br>-Left ventricular ejection fraction (PET)<br>-Mean angina frequency per week<br>-Score Seattle Angina Questionnaire<br>- Natriuretic peptides<br>- Markers of angiogenesis<br>;Timepoint(s) of evaluation of this end point: baseline<br>after 12 weeks of treatment<br>4 weeks after end of treatment