Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-30 @ 4:50 AM
Study NCT ID:
NCT01154504
Status:
WITHDRAWN
Last Update Posted:
2016-11-04
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study
Sponsor:
Federal University of São Paulo
Organization:
Study Overview
Official Title:
The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study
Status:
WITHDRAWN
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We randomized 18 patients, but was impossible to measure adrenomedullin in Brazil. However, we analysed some interesting clinical and laboratorial results.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: