The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study

Last updated: November 2, 2016
Sponsor: Federal University of São Paulo
Overall Status: Trial Not Available

Phase

N/A

Condition

Hyponatremia

Heart Failure

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT01154504
CEP1781/07
  • Ages > 18
  • All Genders

Study Summary

  1. Study Hypothesis:

    -  The decrease of plasma adrenomedullin (ADM) concentration by ultrafiltration and
   isovolumetric hemofiltration in patients with acute III and IV Class New York Heart
   Association Functional(NYHA) heart failure is more pronounced than a standard
   diuretic treatment and is related with clinical improvement.

  2. Outcome Measurements:

To correlate the adrenomedullin plasma levels with clinical treatment, ultrafiltration and hemofiltration related to:

  • Brain natriuretic peptide (BNP) level

  • angiotensin II level

  • sympathetic nervous activity

  • oxydative stress

  • clinical outcome at the beginning, at discharge and 90 days after randomization.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • more than two item:

  • more than eighteen years of age

  • orthopnea

  • Chest Rx with cardiomegaly and pulmonary infiltration

  • edema

  • diuretic resistance

Exclusion

Exclusion Criteria:

  • insulin dependent diabetes

  • hepatic cirrhosis

  • vascular access problems

  • creatinine more than 2,5 mg/dl before acute heart failure

  • systemic infection

  • aortic stenosis and heart transplantation

  • radiologic contrast up to 72 hours prior randomization

  • advanced neoplasia

Study Design

Study Start date:
April 01, 2010
Estimated Completion Date:
December 31, 2012

Study Description

Testing the hypothesis that adrenomedullin (ADM) is a important peptide in severe heart failure and that is related to clinical condition, we will study the effects of 3 different treatments (clinical usual treatment,ultrafiltration and isovolumetric hemofiltration with diuretics) to participants are followed until discharge to Adrenomedullin level and clinical outcomes,and also their relationship with angiotensin II level, brain natriuretic peptide(BNP), sympathetic nervous system and oxydative stress.

The patients will be randomized in three different treatment group and analyzed in three moments: on the randomization, at discharge and 90 days after randomization(plus or minus 3).

The clinical treatment will be optimized, the ultrafiltration will be done until clinically adequate fluid removal or until hematocrit increased 10% from basal level, and isovolumetric hemofiltration will be done for 8 hours- dose of 35 ml/kg/h in association with diuretic. All this dialytic procedures will be done with PAES membrane- filter HF1400 and automatic machine.

Connect with a study center

  • Instituto de Cardiologia

    Porto Alegre, Rio Grande do Sul 94801970
    Brazil

    Site Not Available

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