Underlying cardiovascular disease
Conditions
Interventions
Trade Name: Crataegutt® 450 mg Herz-Kreislauf-Tabletten
Product Name: WS® 1442
Product Code: WS® 1442
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Hawthorn leaf and flower dry extrac
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male outpatients aged 50 years and older 2. Specialist diagnosis of underlying cardiovascular disease a) heart insufficiency, maximum NYHA II b) essential arterial hypertension or c) clinically manifested atherosclerosis 3. Echocardiographic LVEF at rest = 40% 4. Basic therapy of underlying cardiovascular disease 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 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 20
Exclusion criteria
Exclusion criteria: 1. Unstable, severe or acute cardiovascular diseases (acute coronary syndrome, myocardial infarction, instable angina pectoris, hemodynamic valvular defect, hypertrophic obstructive cardiomyopathy, inflammatory cardiac diseases. Stroke, transient ischaemic attack, organ infarction) within the last three months 2. Tachyarrythmic atrial fibrillation 3. Increase of cardiovascular 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 12 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Description of the effects of hawthorn leaf and flower dry extract WS® 1442 on arterial micro-vascular structure and macro-vascular function and laboratory parameters of cardiac stress, endothelial function, oxidative stress and inflammation. • Analysis of the association of these effects with the improvement of the clinical symptoms, exercise capacity and erectile function. ;Secondary Objective: Furthermore the safety and tolerability of hawthorn leaf and flower dry extract WS® 1442 in patients with underlying cardiovascular disease and erectile dysfunction will be analyzed. ;Primary end point(s): Micro-Vascular structure - Ratio Diameter retinal arterioles/venoles;Timepoint(s) of evaluation of this end point: after 8 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Micro-vascular structure: - central retinal arterial equivalent (CARAE) - central retinal venous equivalent (CRVE) Macro-vascular function - pulse wave velocity - cardio-ankle vascular index - amplitude of the forward pulse wave - amplitude of the backward pulse wave - blood pressure - aortal pulse wave velocity - aortal pulse pressure - augmentation pressure - peripheral arterial blood pressure - cardiac ejection time exercise capacity - Oxygen uptake at maximum burden - power at maximum burden - increase of the pressure-rate-product and lactate from rest to 50 watt burden Clinical symptoms - sum value in the Minnesota Living with Heart Failure® Questionnaire Erectile function - sum value in the International Index of Erectile Function - value for erectile function in the International Index of Erectile - questions 2+3 in the Sexual Encounter Profile - measurement of the nocturnal penile tumescence Cardiac burden, endothelial function, oxidative stress and inflammation Parameter venous blood ? NT-proBNP ? ADMA ? BH4/BH2 ? oxLDL/LDL ? MDA ? Plasma-F2-Isoprostane ? Nitrate/Nitrite ? hs-CRP ? IL-6 ? Plasma-Microparticle ;Timepoint(s) of evaluation of this end point: after 8 weeks treatment | — |
Countries
Germany
Contacts
Public ContactMedical Affairs
Dr. Willmar Schwabe GmbH & Co. KG
Outcome results
None listed