Trial document





This trial has been registered retrospectively.
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  DRKS00009993

Trial Description

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Title

WItten heaRt failurE in Aortic Stenosis study - Prospective diagnostic study to investigate the hemodynamic basis of an irreversible left ventricular failure in severe aortic stenosis

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Trial Acronym

WIREAS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

An accompanying heart failure can be caused by pressure overload of the left ventricle in aortic stenosis. A replacement of the diseased aortic valve eliminates the pressure load of the left ventricle and the performance of the heart recovers.
Heart failure can, however, also be due to a damage to the heart muscle. Although a replacement of the diseased aortic valve reduces the pressure load on the heart, but the function of the heart becomes not normal. In these patients, the usefulness of the valve replacement with respect to the improvement of symptoms and normalization of the life expectancy is questionable.
The mechanisms and the differences between the two forms of heart failure in aortic stenosis are not fully understood. In particular, it remains unclear why the cardiac insufficiency in some cases, is reversible and irreversible in others.
Until now, there is no precise hemodynamic analysis of the different forms of heart failure in aortic stenosis.
The aim of the study is therefore to investigate the pathophysiology of heart failure in aortic stenosis. 30 patients are examined with severe aortic valve stenosis and heart failure, which are submitted to aortic valve replacement. As control group serve 10 patients with severe aortic stenosis without heart failure. Hemodynamic studies of the entire heart are performed.

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Brief Summary in Scientific Language

The aim of the present study is to analyze the pathophysiology of irreversible left ventricular dysfunction in aortic stenosis.
For this purpose, 30 patients with symptomatic, severe aortic stenosis and left ventricular dysfunction (left ventricular ejection fraction ≤ 40%) are investigated. Patients are differentiated by their transaortic pressure gradient in a group with "low-flow, low-gradient" and a group with "low-flow, high-gradient" aortic stenosis.
Both study groups are subjected to extensive clinical, echocardiographic and hemodynamic studies. Hemodynamics is compared by the determination of the end-systolic pressure-volume relationship (ESPVR) with and without infusion of dobutamine.
To delineate the myocardial properties of aortic stenosis with left ventricular failure against other forms of aortic stenosis and left ventricular failure, one control group is formed. As control group serve 10 patients with severe aortic stenosis without left ventricular failure.
The primary endpoint is the normalization of left ventricular ejection fraction of ≥ 50% three months after aortic valve replacement. Secondary endpoints include all-cause mortality, cardiovascular mortality, hospitalization for heart failure and the distance in the 6-minute walk test.

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Organizational Data

  •   DRKS00009993
  •   2016/02/16
  •   [---]*
  •   yes
  •   Approved
  •   4379-12, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   I35.0 -  Aortic (valve) stenosis
  •   I42.8 -  Other cardiomyopathies
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Interventions/Observational Groups

  •   Invasive and non-invasive hemodynamic analyzes in patients with severe aortic stenosis (valve area <1 cm ²) with a left ventricular dysfunction (left ventricular ejection fraction ≤ 40%) and a transaortic gradient of > 40 mmHg before aortic valve replacement. Non-invasive hemodynamic analyzes 3 months after aortic valve replacement.
  •   Invasive and non-invasive hemodynamic analyzes in patients with severe aortic stenosis (valve area <1 cm ²) with a left ventricular dysfunction (left ventricular ejection fraction ≤ 40%) and a transaortic gradient of ≤ 40 mmHg before aortic valve replacement. Non-invasive hemodynamic analyzes 3 months after aortic valve replacement.
  •   Invasive and non-invasive hemodynamic analyzes in patients with severe aortic stenosis (valve area <1 cm ²) without left ventricular dysfunction (left ventricular ejection fraction > 40%) before aortic valve replacement. Non-invasive hemodynamic analyzes 3 months after aortic valve replacement.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Comparison of reversible and irreversible left ventricular failure in terms of the end-systolic pressure-volume relationship (ESPVR) - measured with conductance catheter - before aortic valve replacement

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Secondary Outcome

Comparison of reversible and irreversible left ventricular failure:
- All-cause mortality (one-year)
- Cardiovascular mortality (one-year)
- Hospitalization for heart failure (within the first year after aortic valve replacement)
- Distance in the 6-minute walk test before and 3 months after aortic valve replacement

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/10/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Inclusion criteria study group aortic stenosis and left ventricular failure
- Severe aortic stenosis ( valve area < 1 cm ²)
- Left ventricular dysfunction (left ventricular ejection fraction ≤ 40%)
- Symptoms of heart failure (NYHA II -IV)
- Age ≥ 18 years
- Life expectancy > 1 years
- Consent to participate in the study

Inclusion criteria control group aortic stenosis without left ventricular failure
- Severe aortic stenosis ( valve area < 1 cm ²)
- Received left ventricular ejection fraction ( ≥ 50%)
- Symptoms of heart failure (NYHA II -IV)
- Age ≥ 18 years
- Life expectancy > 1 years
- Consent to participate in the study

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Exclusion Criteria

- Active endocarditis
- Previous heart surgery
- Concurrent serious stenosis or insufficiency of the mitral valve
- Concurrent serious insufficiency of the aortic valve
- Pregnancy, lactation

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Addresses

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    • Kardiogische Klinik, Marien-Hospital Witten, Ruhr-Universität Bochum
    • Mr.  Priv. Doz. Dr. med.  Michael  Gotzmann 
    • Marienplatz 2
    • 58452  Witten
    • Germany
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    • Kardiogische Klinik, Marien-Hospital Witten, Ruhr-Universität Bochum
    • Mr.  Priv. Doz. Dr. med.  Michael  Gotzmann 
    • Marienplatz 2
    • 58452  Witten
    • Germany
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    • Kardiogische Klinik, Marien-Hospital Witten, Ruhr-Universität Bochum
    • Mr.  Priv. Doz. Dr. med.  Michael  Gotzmann 
    • Marienplatz 2
    • 58452  Witten
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Stiftung für Herzforschung
    • Vogtstraße 50
    • 60322  Frankfurt
    • 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.