Clinical trial NCT01154504: The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study
Official title: The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Keywords: adrenomedullin
heart failure
ultrafiltration
hemofiltration
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* more than two item:

  * more than eighteen years of age
  * orthopnea
  * Chest Rx with cardiomegaly and pulmonary infiltration
  * edema
  * diuretic resistance

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

Primary outcomes:
measure: Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
timeFrame: 90 days after randomization (plus or minus 3 days).
measure: Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
timeFrame: at discharge
Secondary outcomes:
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.
timeFrame: at discharge
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.
timeFrame: 90 days after randomization (plus or minus 3)
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress
timeFrame: at discharge
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress
timeFrame: 90 days after randomization(plus or minus 3)
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level
timeFrame: at discharge
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level
timeFrame: 90 days after randomization(plus or minus 3)
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to Brain natriuretic peptide plasma level
timeFrame: at discharge
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to Pro-Brain natriuretic peptide plasma level
timeFrame: 90 days after randomization(plus or minus 3)
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to sympathetic nervous system activity
timeFrame: at discharge
measure: The Adrenomedullin plasma levels in three different treatment approaches will be related to sympathetic nervous system activity
timeFrame: 90 days after randomization(plus or minus 3)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia
state: Rio Grande do Sul
Study officials:
References: