NCT01154504

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	clinical treatment	The clinical treatment will be optimized to gold standard international heart failure treatment
PROCEDURE	ultrafiltration	The ultrafiltration procedure will be done on Intensive Care Unit with automatic machine and HF 1400 filter. The fluid will be removed until a increased of 10% in hematocrit or clinical improvement.
PROCEDURE	isovolumetric hemofiltration	The isovolumetric hemofiltration will be done in Intensive Care Unit for 8 hours, and will be permitted the diuretic use.The dose will be 35 ml/kg/hour and will e used automatic machine and MF1400 filter.Diuretic use will be maintained.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-12-01
• Completion: 2012-12-01
• First posted: 2010-07-01
• Last updated: 2016-11-04

Locations

1 site across 1 country: Brazil