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

NCT ID: NCT01154504

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Heart Failure

Keywords

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adrenomedullin heart failure ultrafiltration hemofiltration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clinical treatment

Patients with previous diagnosis of decompensated III and IV Heart Failure will be included. The clinical treatment will be optimized.

Clinical assessment, Adrenomedullin, Angiotensin II, Brain Natriuretic Peptide, oxydative stress, sympathetic nervous system activity will be evaluated at the beginning, at discharge and 90 days after randomization(plus or minus3).

Group Type OTHER

clinical treatment

Intervention Type OTHER

The clinical treatment will be optimized to gold standard international heart failure treatment

ultrafiltration

ultrafiltration will be done on decompensated patients III and IV acute heart failure on Intensive Care Unit. This patients will have biochemical analysis, adrenomedullin, angiotensin II,Brain Natriuretic Peptide, oxydative stress measurements,sympathetic nervous system activity evaluated and clinical outcome analyzed at the beginning,at discharge and 90 days after randomization(plus or minus 3).

Diuretic will be withdrawn during ultrafiltration.

Group Type EXPERIMENTAL

ultrafiltration

Intervention Type PROCEDURE

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

Patients randomized to this group will have isovolumetric hemofiltration on Intensive Care Unit. They will have biochemical analysis, Adrenomedullin plasmatic level, Brain Natriuretic Peptide Level, Angiotensin II level, Oxydative stress measurement,sympathetic nervous system, and clinical outcome evaluated at the study beginning,at discharge and 90 days after randomization(plus or minus 3).

Group Type EXPERIMENTAL

isovolumetric hemofiltration

Intervention Type PROCEDURE

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.

Interventions

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clinical treatment

The clinical treatment will be optimized to gold standard international heart failure treatment

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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adrenomedullin dialysis adrenomedullin hemofiltration dialysis adrenomedullin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Anna Stein

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP1781/07

Identifier Type: -

Identifier Source: org_study_id