Decompensated Heart FailureNCT00355017
BNP Guided Care in Addition to Multidisciplinary Care
A study testing BNP-guided care in addition to multidisciplinary management in people with Decompensated Heart Failure, run by Medical University of Vienna.
Trial summary
HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM) improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after discharge. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Decompensated Heart Failure
- What is being tested?
- BNP-guided care in addition to multidisciplinary management
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2003to Sep 2005
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs and symptoms of cardiac decompensation during the present hospitalisation
- NYHA class III or IV at time of admission
- Cardiothoracic ratio > 0.5, and/or left ventricular ejection fraction <40% documented by echocardiography
Who cannot join
- -
About this study
Official title: NT-BNP Guided Care in Addition to Multidisciplinary Care in Patients With Chronic Heart Failure A Three-Arm, Prospective, Randomised Study
HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM) improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after discharge.
Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days and 2 months after discharge for recommending medical optimisation and care by a specialised HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified increase of medical treatment during repeated follow-up visits in a HF clinic in patients with an Nt-BNP level above 2200pg/ml at discharge.
- Conditions
- Decompensated Heart Failure
- Being tested
- BNP-guided care in addition to multidisciplinary management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNP-guided care in addition to multidisciplinary managementProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure rehospitalisation rate;
combined endpoint death or heart failure rehospitalisation;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startSep 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Richard Pacher, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355017
- Sponsor's protocol ID
- VF: 05.05.2003
- Status last verified
- Jul 2006
- First submitted
- 19 Jul 2006
- Last updated
- 18 Oct 2006
- Results posted
- No
Publications
Berger R, Moertl D, Peter S, Ahmadi R, Huelsmann M, Yamuti S, Wagner B, Pacher R. N-terminal pro-B-type natriuretic peptide-guided, intensive patient management in addition to multidisciplinary care in chronic heart failure a 3-arm, prospective, randomized pilot study. J Am Coll Cardiol. 2010 Feb 16;55(7):645-53. doi: 10.1016/j.jacc.2009.08.078.
PubMed 20170790
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT-BNP Guided Care in Addition to Multidisciplinary Care in Patients With Chronic Heart Failure A Three-Arm, Prospective, Randomised Study
- ClinicalTrials.gov ID
- NCT00355017
- Acronym / sponsor ID
- VF: 05.05.2003
- Conditions
- Decompensated Heart Failure
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Sep 2005
- First posted
- 20 Jul 2006 (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.
HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM) improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after discharge.
Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days and 2 months after discharge for recommending medical optimisation and care by a specialised HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified increase of medical treatment during repeated follow-up visits in a HF clinic in patients with an Nt-BNP level above 2200pg/ml at discharge.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical signs and symptoms of cardiac decompensation during the present hospitalisation
- NYHA class III or IV at time of admission
- Cardiothoracic ratio > 0.5, and/or left ventricular ejection fraction <40% documented by echocardiography
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BNP-guided care in addition to multidisciplinary management | Procedure or surgery | – |
Primary outcome
Heart failure rehospitalisation rate;
combined endpoint death or heart failure rehospitalisation;
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2006.
- Derived from this study: PubMed 20170790Berger R, Moertl D, Peter S, Ahmadi R, Huelsmann M, Yamuti S, Wagner B, Pacher R. N-terminal pro-B-type natriuretic peptide-guided, intensive patient management in addition to multidisciplinary care in chronic heart failure a 3-arm, prospective, randomized pilot study. J Am Coll Cardiol. 2010 Feb 16;55(7):645-53. doi: 10.1016/j.jacc.2009.08.078.
Related trials for Decompensated Heart Failure
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
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.
Richard Pacher, MD principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A study testing BNP-guided care in addition to multidisciplinary management in people with Decompensated Heart Failure, run by Medical University of Vienna.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early. Results are not available in the source record.
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?
Heart failure rehospitalisation rate;. 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?
On the ClinicalTrials.gov record for NCT00355017, which also lists 1 linked publication.
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 18 Oct 2006.