Monocenter prospective open single-arm phase IV study of the effects ofhawthorn extract WS® 1442 on arterial micro-vascular structure andmacro-vascular function, exercise capacity and erectile function of male patients with cardiovascular primary disease and erectile dysfunctio
- Conditions
- MedDRA - 10019279 (Heart failure)
- Registration Number
- DRKS00010226
- Lead Sponsor
- Dr. Willmar Schwabe GmbH &Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- Male
- Target Recruitment
- 35
1. Male outpatients aged 50 years and older
2. Diagnosis of cardiovascular primary disease
a) heart failure, max. NYHA II
b) essential arterial Hypertension
c) clinically apparent atherosclerosis
3. Echocardiographic LVEF at rest = 40%
4. Basic therapy of diastolic heart failure according to current guidelines
5. Unchanged basic therapy for at least 4 weeks
6. Erectile dysfunction (less than 22 Points in the International Index of Erectile Function)
7. Written informed consent
8. Willingness and ability to participate all study specific tasks
1. Instable, severe or acute cardiac diseases (acute coronary syndrome,
myocardial infarction, instable angina pectoris, hemodynamic valvular
defect, hypertrophic obstructive cardiomyopathy, inflammatory cardiac
diseases) within the last three months
2. Tachyarrythmic atrial fibrillation
3. Increase of cardiac complaints in the last seven days
4. Antihypertensives from more than two substance classes (ACE-Inhibitors,
angiotensin II receptor antagonists, diuretics, beta-blockers,
calcium antagonists, direct vasodilators, central acting
antihypertensives)
5. Treatment with digitalis
6. Treatment with hawthorn or another herbal cardiovascular medication
7. Treatment of erectile dysfunction
8. Hypersensitivity towards other ingredients of the study medication
9. Participation in other clinical trials within the last 4 weeks
10. Ankle-brachial-index < 0,9
11. Alcohol or drug abuse or dependence
12. Acute or severe generalized diseases in the last 4 weeks
13. Acute or chronic psychiatric diseases
14. Planned hospitalization during study participation
15. Contagious skin and venereal diseases, rash or injury at the penis or around this area
16. Other factors that prevent from study participation (e.g. acute
psychosocial burden, insufficient understanding of the content and scope
of the study, insufficient knowledge of German language)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Micro-Vascular structure<br>- Measurement of ratio of the diameters of retinal arterioles and venoles by Static Retinal Vessel Analyzer (SVA-T) during visit 2 and 4<br>
- Secondary Outcome Measures
Name Time Method - Additional parameters of micro-vascular structure by Static Retinal Vessel Analyzer (SVA-T) during visit 2 and 4<br>- Parameters of arterial stiffness by Vasera during visit 2 and 4<br>- Cardiac burden, endothelial function, oxidative stress and inflammation (parameters in venous blood) during visit 2 and 4<br>- exercise capacity in bike spiroergometry during visit 2 and 4<br>- Clinical symptoms at all visits (Quality of Life Questionnaire in heart failure, questionnaire on erectile function, diary for sexual activity)<br>- Measurement of penile tumescence by RigiScan during visit 2 and 4<br>- Safety and tolerability<br>