Heart FailureNCT01154504
The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study
A study testing clinical treatment, ultrafiltration and isovolumetric hemofiltration in people with Heart Failure, run by Federal University of São Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- clinical treatment, ultrafiltration and isovolumetric hemofiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than two item:
- more than eighteen years of age
- orthopnea
- Chest Rx with cardiomegaly and pulmonary infiltration
- edema
- diuretic resistance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia
Porto Alegre, Rio Grande do Sul, 94801970
About this study
- 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.
- 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.
Read the 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
- Being tested
- clinical treatment, ultrafiltration, isovolumetric hemofiltration
- Keywords
- adrenomedullin, heart failure, ultrafiltration, hemofiltration
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical treatmentOther
Also called adrenomedullin
The clinical treatment will be optimized to gold standard international heart failure treatment
ultrafiltrationProcedure or surgery
Also called dialysis, adrenomedullin
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 hemofiltrationProcedure or surgery
Also called hemofiltration, dialysis, adrenomedullin
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.
| Study group | Role | What they receive |
|---|---|---|
| clinical treatment | Other | 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). Receives: Other: clinical treatment |
| ultrafiltration | Experimental | 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. Receives: Procedure: ultrafiltration |
| isovolumetric hemofiltration | Experimental | 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). Receives: Procedure: isovolumetric hemofiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after randomization (plus or minus 3 days).
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.
Measured: at discharge
Secondary outcomes (10)
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
Measured: at discharge
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.
Measured: 90 days after randomization (plus or minus 3)
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.
Measured: at discharge
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.
Measured: 90 days after randomization(plus or minus 3)
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.
Measured: at discharge
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.
Measured: 90 days after randomization(plus or minus 3)
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.
Measured: at discharge
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)
Measured: 90 days after randomization(plus or minus 3)
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.
Measured: at discharge
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.
Measured: 90 days after randomization(plus or minus 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2012
Why it stopped: We randomized 18 patients, but was impossible to measure adrenomedullin in Brazil. However, we analysed some interesting clinical and laboratorial results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Stein, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154504
- Sponsor's protocol ID
- CEP1781/07
- Status last verified
- Nov 2016
- First submitted
- 28 Jun 2010
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study
- ClinicalTrials.gov ID
- NCT01154504
- Acronym / sponsor ID
- CEP1781/07
- Conditions
- Heart Failure
- Keywords
- adrenomedullin, heart failure, ultrafiltration, hemofiltration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We randomized 18 patients, but was impossible to measure adrenomedullin in Brazil. However, we analysed some interesting clinical and laboratorial results.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clinical treatment | Other | Other: clinical treatmentPatients 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). |
| ultrafiltration | Experimental | Procedure: ultrafiltrationultrafiltration 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. |
| isovolumetric hemofiltration | Experimental | Procedure: isovolumetric hemofiltrationPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- more than two item:
Key exclusion criteria (8 listed)
- insulin dependent diabetes
- hepatic cirrhosis
- vascular access problems
- creatinine more than 2,5 mg/dl before acute heart failure
- systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical treatmentAlso: adrenomedullinThe clinical treatment will be optimized to gold standard international heart failure treatment | Other | clinical treatment |
| ultrafiltrationAlso: dialysis, adrenomedullinThe 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 or surgery | ultrafiltration |
| isovolumetric hemofiltrationAlso: hemofiltration, dialysis, adrenomedullinThe 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. | Procedure or surgery | isovolumetric hemofiltration |
Primary outcome
Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
Time frame: 90 days after randomization (plus or minus 3 days).
The adrenomedullin level will be compared in three different treatments: clinical treatment, ultrafiltration treatment and isovolumetric hemofiltration.
Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
Time frame: at discharge
The adrenomedullin level will be compared in three different treatments: clinical treatment, ultrafiltration treatment and isovolumetric hemofiltration. The patients will be followed until discharge.
10 secondary outcomes
The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.
Time frame: at discharge
The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.
Time frame: 90 days after randomization (plus or minus 3)
The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress
Time frame: at discharge
The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress
Time frame: 90 days after randomization(plus or minus 3)
The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level
Time frame: at discharge
The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level
Time frame: 90 days after randomization(plus or minus 3)
The Adrenomedullin plasma levels in three different treatment approaches will be related to Brain natriuretic peptide plasma level
Time frame: at discharge
The Adrenomedullin plasma levels in three different treatment approaches will be related to Pro-Brain natriuretic peptide plasma level
Time frame: 90 days after randomization(plus or minus 3)
The Adrenomedullin plasma levels in three different treatment approaches will be related to sympathetic nervous system activity
Time frame: at discharge
The Adrenomedullin plasma levels in three different treatment approaches will be related to sympathetic nervous system activity
Time frame: 90 days after randomization(plus or minus 3)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical treatment, ultrafiltration and isovolumetric hemofiltration in people with Heart Failure, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration (time frame: 90 days after randomization (plus or minus 3 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.