Trial document





This trial has been registered retrospectively.
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  DRKS00000272

Trial Description

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Title

BIRTH: Prospective analysis of BNP-Levels in recompensation therapy in heart failure

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Trial Acronym

BIRTH

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URL of the Trial

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Brief Summary in Lay Language

The trial evaluates patients with acute congestive heart failure. We investigate whether a treatment success in patients with acute congestive heart failure can be monitored via a blood test measuring BNP (brain natriuretic peptide) in plasma. BNP is a laboratory marker which is used for the diagnosis of heart failure. Its use as a therapy monitor would enable us to better adapt the treatment to the individual patients needs. Besides BNP testing, we also perform other diagnostic tests like patient self assessment questionnaires and a six-minute walking test to find out whether BNP and/or any of these tests can help to predict a patients risk profile for the future.

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Brief Summary in Scientific Language

BNP has proofed to be a sensitive and specific marker fort he diagnosis and prognosis of heart failure, but there are few and contradicting data on using BNP to assess recompensation therapy.
We evaluate the potential use of BNP as a procnostic marker and for therapy monitoring by analyzing serial blood samples from the patients admission to the Emergency Department until their discharge after recompensation therapy.
We also perform a range of diagnostic tests which we will assess for their use in the risk stratification of patients with acute heart failure. These tests include patient self assessment questionnaires (MLHFQ, SF-36) and a 6 minute walking test (6MWT).

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Organizational Data

  •   DRKS00000272
  •   2009/12/14
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  •   yes
  •   Approved
  •   159/2003, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1112-8716 
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Health Condition or Problem studied

  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Heart failure (HF) was treated following the recommended guidelines as documented in our standard operating procedures (www.charite.de/kardiologie)
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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)
  •   N/A
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Primary Outcome

Cardiovascular Death and Re-admission to hospital for acute congestive heart failure, Assessment during telephone follow-up 1 year after index admission to the Emergency Department

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Secondary Outcome

Death of acute heart failure, Assessment during 1-year telephone follow-up. || Improvement of NYHA classification score, Evaluation by study physician during clinical assessment and questionning in telephone follow-up || Improvement of the patients physical ability. In order to evaluate the patient's physical constitution a 6-min walk test (6MWT) was performed according to Guyatt et al. Patients were asked to walk at a fast pace until exhaustion occurred or for a period of 6 min on a level surface 50 m in length. The total distance walked (in m) during the test was recorded. All tests were administered by one physician who was unaware of the MLHFQ and laboratory data. The 6-min walking test was assessed on the first day after admission, at day 2, 3, 5 and at discharge from the hospital. || Improvement of LV ejection fraction: Transthoracic echocardiography was performed within 24h after admission following international standards with respect to left ventricular function, diameters and valve function. The ejection fraction was determined using the Teichholz-formula on 5 consecutive heart cycles. In case of arrhythmias (predominately atrial fibrillation) ten cycles were analyzed. || Developing of BNP values during the course of standard heart failure therapy: For the BNP analysis, EDTA plasma was frozen at -20C° . BNP levels (in pg/ml) were measured at baseline and in inpatients at days 1, 2, 3 and 5 after admission as well as at discharge. || Score of the Self-assessment of patients quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ):
To assess quality of life, patients filled in a cross-cultural adaptation of the Minnesota Living with Heart Failure Questionnaire for German-speaking patients. The test ranged between 0 (no disability) and 100 (severe disability). The questionnaire was completed within 24 hours after admission. || Score of self-assessment health status with the SF-36: The SF-36 is currently the most widely used patient self assessment questionnaire to evaluate the subjective health status. It has been used in more than 9000 different studies. It has 36 items, which can be scaled on 8 scales and/or 2 composite scores. For this study we used two composite scores (Physical Component Score PCS and Mental Component Score MCS). The questionnaire was completed within 24 hours after admission.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2004/01/15
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

-Acute congestive heart failure NYHA III-IV

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Exclusion Criteria

- Acute ST-elevation myocardial infarction
- Anemia (Hb < 10 g/dL)
- Cardiac surgery within the last 4 weeks
- Malignoma
- Inability to give written informed consent
- Age under 18 years

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Addresses

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    • Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Medizinische Klinik m.S. Kardiologie Internistische Notaufnahme
    • Mr.  Prof. Dr.  Martin  Möckel 
    • Augustenburger Platz 1
    • 14195  Berlin
    • Germany
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    • Vivantes Klinikum Neukölln Klinik für Innere Medizin - Kardiologie und konservative Intensivmedizin
    • Mr.  Dr. med.  Daniel  Weinrich 
    • Rudower Strasse 48
    • 12351  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin Campus Virchow Klinikum Med. Klinik m.S. Kardiologie Internistische Notaufnahme
    • Ms.  Dr. med.  Julia  Searle 
    • Augustenburger Platz1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bayer Vital GmbH
    • Mr.  Dr.  H.  Butz 
    • Siemensstrasse 3
    • 35463  Fernwald
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2007/12/01
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Trial Publications, Results and other Documents

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