Effect of 8 weeks oral pentaerithrityltetranitrate on endothelial dysfunction in patients with coronary artery disease: a prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Men or women > 35 and < 80 years of age
2. Documented clinically stable CAD with stable angina pectoris
3. Ability of subject to understand the character and individual consequences of the clinical trial
4. Written informed consent must be available before enrollment in the trial
5. For women with childbearing potential, adequate contraception (oral contraceptives or intrauterine devices) is required

Exclusion Criteria

1. Clinical signs of congestive heart failure or left ventricular ejection fraction <30% (as demonstrated within the last 1 year by echocardiography, Left Ventricular [LV] angiography, Magnetic Resonance Imaging [MRI] or radionuclide ventriculography, respectively)
2. Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <110 mmHg)
3. Initiation of any of the following medications within the last 8 weeks: aspirin, statins, calcium antagonists, Angiotensin Converting Enzyme (ACE)-inhibitors or AT1 receptor blockers, hormone replacement therapy. Individuals who take any of these drugs longer than 8 weeks can be included in this trial.
4. Use of Phosphodiesterase-5-inhibitors (Viagra®, Revatio®, Cialis®, Levitra®), dihydroergotamine and nitrates i.e. isosorbidemononitrate, isosorbidedinitrate, nitroglycerin, pentaerithrityltetranitrate or molsidomin within the last two weeks.
5. Hemodynamically significant aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy (as demonstrated within the last year by echocardiography, invasive right/ left heart catherterization or MRI, respectively)
6. Renal dysfunction (plasma creatinine [men: > 2.0 mg/dl, women: > 1.8 mg/dl])
7. Known hepatic disease or elevation of serum transaminases or gGT > 3 x Upper Limit of Normal range (ULN)
8. White Blood Cells (WBC) >16.000 or platelet count >500.000/µl or <75.000/µl
9. Clinically overt hyperthyreodism
10. Pregnancy and lactation
11. Known intolerance to organic nitrates
12. Known lactose intolerance
13. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
14. Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study
15. In other clinical trials and observation period of competing trials, respectively

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FMD at baseline and after 8 weeks of treatment, measured by high-resolution ultrasound of the right brachial artery diameter percentage change upon reactive hyperemia after 5 minutes suprasystolic occlusion of the upper arm.

Secondary Outcome Measures

Name	Time	Method
<br> The following will also be assessed at baseline and after 8 weeks of treatment:<br> 1. Cardiovascular biomarkers (high-sensitivity C-Reactive Protein [hs-CRP], lipid profile, ferritin, bilirubin, uric acid)<br> 2. Endothelium-independent nitrogylcerin-induced vasodilation (NMD)<br> 3. Endo-PAT2000 (device for assessing endothelial function) reactive hyperemia index<br>

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