Trial document




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  DRKS00010226

Trial Description

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Title

Monocenter prospective open single-arm phase IV study of the effects of
hawthorn extract WS® 1442 on arterial micro-vascular structure and
macro-vascular function, exercise capacity and erectile function of male patients with cardiovascular primary disease and erectile dysfunction

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is the measurement of effects of hawthorn extract WS ®1442 on arterial structure and function in men with cardiovascular primary disease and erectile dysfunction and to evaluate the relation of these effects to improvement of clinical symptoms, exercise capacity and erectile function
(Change of protocol title due to the change of inclusion- and exclusion criteria)

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Brief Summary in Scientific Language

Objectives of the study
- Description of the effects of hawthorn extract WS® 1442 on arterial micro-vascular structure and macro-vascular function as well as laboratory parameters of cardiac burden, endothelial function, oxidative stress and inflammation.

- Analysis of the relation of these effects to improvements in clinical symptoms, exercise capacity and erectile function.

- Description of safety and tolerability of hawthorn extract WS® 1442 in patients with cardiovascular primary disease and erectile dysfunction.

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Organizational Data

  •   DRKS00010226
  •   2016/03/25
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  •   no
  •   Approved
  •   7006M mono, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   2014-001319-38 
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Health Condition or Problem studied

  •   10019279 (Heart failure)
  •   N48.4 -  Impotence of organic origin
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Interventions/Observational Groups

  •   The aim of the study is the measurement of effects of hawthorn extract WS ®1442 on arterial structure and function in men with cardiovascular primary disease and erectile dysfunction and to evaluate the relation of these effects to improvement of clinical symptoms, exercise capacity and erectile function
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Micro-Vascular structure
- Measurement of ratio of the diameters of retinal arterioles and venoles by Static Retinal Vessel Analyzer (SVA-T) during visit 2 and 4

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Secondary Outcome

- Additional parameters of micro-vascular structure by Static Retinal Vessel Analyzer (SVA-T) during visit 2 and 4
- Parameters of arterial stiffness by Vasera during visit 2 and 4
- Cardiac burden, endothelial function, oxidative stress and inflammation (parameters in venous blood) during visit 2 and 4
- exercise capacity in bike spiroergometry during visit 2 and 4
- Clinical symptoms at all visits (Quality of Life Questionnaire in heart failure, questionnaire on erectile function, diary for sexual activity)
- Measurement of penile tumescence by RigiScan during visit 2 and 4
- Safety and tolerability

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/08/18
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

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

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Exclusion Criteria

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)

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Addresses

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    • Dr. Willmar Schwabe GmbH &Co. KG
    • Willmar- Schwabe- Str. 4
    • 76227  Karlruhe
    • Germany
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    • Dr. Willmar Schwabe GmbH & Co. KG
    • Mr.  Dr.  Martin  Burkart 
    • Bunsenstraße 6-10
    • 76275  Ettlingen
    • Germany
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    • Dr. Willmar Schwabe GmbH & Co. KG
    • Mr.  Dr.  Martin  Burkart 
    • Bunsenstraße 6-10
    • 76275  Ettlingen
    • Germany
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Sources of Monetary or Material Support

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    • Dr. Willmar Schwabe GmbH &Co. KG
    • Willmar- Schwabe- Str. 4
    • 76227  Karlsruhe
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.