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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01154504
• Other study ID #: CEP1781/07
• Status: Withdrawn
• Phase: N/A
• First received: June 28, 2010
• Last updated: November 2, 2016
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration	The adrenomedullin level will be compared in three different treatments: clinical treatment, ultrafiltration treatment and isovolumetric hemofiltration.	90 days after randomization (plus or minus 3 days).	Yes
Primary	Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration	The adrenomedullin level will be compared in three different treatments: clinical treatment, ultrafiltration treatment and isovolumetric hemofiltration. The patients will be followed until discharge.	at discharge	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.	The correlation of adrenomedullin plasma levels in all 3 arms related to optimized clinical outcome. The patients will be followed until discharge	at discharge	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.	The correlation of adrenomedullin plasma levels in all 3 arms related to optimized clinical outcome.	90 days after randomization (plus or minus 3)	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress	The correlation of adrenomedullin plasma levels in all 3 arms related to oxydative stress. The patients will be followed until discharge.	at discharge	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress	The correlation of adrenomedullin plasma levels in all 3 arms related to oxydative stress.	90 days after randomization(plus or minus 3)	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level	The correlation of adrenomedullin plasma levels in all 3 arms related to angiotensin II level. The patients will be followed until discharge.	at discharge	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level	The correlation of adrenomedullin plasma levels in all 3 arms related to angiotensin II plasma level.	90 days after randomization(plus or minus 3)	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to Brain natriuretic peptide plasma level	The correlation of adrenomedullin plasma levels in all 3 arms related to Brain natriuretic peptide level. The patients will be followed until discharge.	at discharge	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to Pro-Brain natriuretic peptide plasma level	The correlation of adrenomedullin plasma levels in all 3 arms related to Brain natriuretic peptide level, 90 days after randomization(plus or minus 3)	90 days after randomization(plus or minus 3)	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to sympathetic nervous system activity	The correlation of adrenomedullin plasma levels in all 3 arms related to sympathetic nervous system.The patients will be followed until discharge.	at discharge	Yes
Secondary	The Adrenomedullin plasma levels in three different treatment approaches will be related to sympathetic nervous system activity	The correlation of adrenomedullin plasma levels in all 3 arms related to sympathetic nervous system.	90 days after randomization(plus or minus 3)	Yes