Trial document




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  DRKS00000259

Trial Description

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Title

Monocentric prospective randomized controlled open phase IV study to explorate the mechanismen of the
synergetic effect of the Crateagus -Extract WS® 1442 in addition to endurance training related to quality
of life of patients with limited physical potential caused by cardiovascular disease (Heart Failure Stade
NYHA II)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The trial will evaluate the mechanisms, by which WS® 1442 in combination with moderate endurance training improves quality of life in patients with mild heart failure (NYHA II).

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Brief Summary in Scientific Language

Explorative phase IV trial to identify mechanisms, by which WS® 1442 in combination with moderate endurance training improves quality of life in patients with mild heart failure (NYHA II).

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Organizational Data

  •   DRKS00000259
  •   2009/11/12
  •   [---]*
  •   no
  •   Approved
  •   2009-111, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   2009-015005-39 
  •   4035675 
  •   MW005  (Dr. Willmar Schwabe GmbH & Co. KG)
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Health Condition or Problem studied

  •   I50.12 -  [generalization I50.1: Left ventricular failure]
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Interventions/Observational Groups

  •   WS(R) 1442 900 mg/day oral treatment and endurance exercise training
  •   endurance exercise training
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   IV
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Primary Outcome

none, as the trial is exploratory

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Secondary Outcome

Quality of life, questionnaire, weeks 0 and 8 || working capacity, ergometry, weeks 0 and 8 || efficiency of muscular work, ergometry, weeks 0 and 8 || cardiac output during exercise, plethysmography, weeks 0 and 8 || vascular function during exercise, plethysmography, weeks 0 and 8 || muscular oxygen saturation during exercise, NIRS, weeks 0 and 8 || adverse events, throughout trial

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/12/21
  •   140
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   46   Years
  •   no maximum age
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Additional Inclusion Criteria

-heart failure NYHA II
- at least one of the following underlying diseases: chronic coronary heart disease, non-acute non-ischaemic cardiomyopathy, arterial hypertension, nomofrequent atrial fibrillation, vitium Grade 1. or 2., condition after cardiac valve replacement
- LVEF at rest > 40%
- NT-pro-BNP < 450 ng /l
- too little physical activity
- existence of at least two cardiovascular riskf actors
- stable cardiac bachground treatment for at least 4 weeks
- cardiac drug therapy according to guidelines
- willing and able to complete the trial and to take part in all trial prosedures as described in the protocol
- female patients with child bearing potential must have a negative pregnancy test and have to use a safe birth control method

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Exclusion Criteria

- acute or severe cardiac disease within the last three months
- tachyarrhytmic atrial fibrillation
- patients with pacemaker or ICD
- worsening of the cardiac disorder within the last 7 days
- intake of hawthorn preparationor of any other cardiovascular active herbal preparation
- acute or chronic psychiatric disorder
- hypersensitivity to any of the drug ingredients
- participation in any other clinical tria within the last 4 weeks
- pregnant or lactating women
- alcohol or drug abuse or dependency
- planned hospitalization during the course of the study
- subjects who are otherwise unsuitable for the participation in this trial
- treatment with cardiac glycosoides
- severe or acute general disease within the last 4 weeks

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Addresses

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    • Dr. Willmar Schwabe GmbH & Co. KG
    • Willmar-Schwabe Strasse 4
    • 76227  Karlsruhe
    • Germany
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    • Dr. Willmar Schwabe GmbH & Co. KG
    • Ms.  Dr. med.  Astrid  Albrecht 
    • Willmar-Schwabe Str. 4
    • 76227  Karlsruhe
    • Germany
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    • Dr. Willmar Schwabe GmbH & Co. KG
    • Ms.  Dr. med.  Astrid  Albrecht 
    • Willmar-Schwabe Str. 4
    • 76227  Karlsruhe
    • Germany
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Sources of Monetary or Material Support

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    • Dr. Willmar Schwabe GmbH & Co. KG
    • Willmar-Schwabe-Straße 4
    • 76227  Karlsruhe
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/04/19
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Trial Publications, Results and other Documents

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