Heart FailurePhase 4NCT01299350
Nt-proBNP Versus Clinical Guided Discharge in Acute Heart Failure
A Phase 4 study testing Nt-proBNP guided discharge in people with Heart Failure, run by University of Valencia at 1 site in Spain.
Trial summary
Our objective is to compare a policy of hospital discharge guided by NT-proBNP levels versus discharge guided by conventional clinical criteria, in patients admitted with acute heart failure. The hypothesis is that the Nt-proBNP guided discharge will shorten hospital stay without worsening the outcome 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?
- Nt-proBNP guided discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2010to Mar 2013
- Phase
- Phase 4
- 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
- clinical signs and symptoms of acute heart failure, according to the criteria of the European guidelines
- NT-proBNP levels > 1000 pg/ml at the time of admission
- age over 18 years old
- signed informed consent
Who cannot join
- GFR less than 30 ml/minute/m2,
- life expectancy as determined by concomitant diseases under one year,
- acute coronary syndrome within 10 days prior,
- valvular heart disease with surgical approach,
- infection or process active malignancy,
- chronic respiratory failure with pulmonary disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison Between Nt-proBNP or Clinical Guided Discharges in Patients Hospitalized With Acute Heart Failure
Our objective is to compare a policy of hospital discharge guided by NT-proBNP levels versus discharge guided by conventional clinical criteria, in patients admitted with acute heart failure. The hypothesis is that the Nt-proBNP guided discharge will shorten hospital stay without worsening the outcome
Read the detailed description
Nt-proBNP levels as well as their response to pharmacological treatment are predictive of prognosis in patients with heart failure. The purpose of the present project is to investigate, in patients hospitalized with acute heart failure, whether a discharge decision guided by Nt-proBNP response shortens hospital stay and improves prognosis The included patients will be randomly assigned to one of these two strategies: hospital discharge according to clinical conventional criteria or discharge guided by Nt-proBNP. All patients will be treated following clinical guidelines. In the guided Nt-proBNP strategy, patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. In the conventional strategy, patients will be discharged at criterion of the attending cardiologist according to clinical assessment without Nt-proBNP. The main outcome will be the number of days of hospitalization at the index episode, and the secondary outcome will be death or readmission by heart failure at one and 6 months. Our hypothesis is that the Nt-proBNP guided discharge will allow to precisely evaluate the response to treatment and to determine the best time for hospital discharge. This will reduce hospital stay and death or readmission rate after discharge.
- Conditions
- Heart Failure
- Being tested
- Nt-proBNP guided discharge
- Keywords
- Heart failure, Nt-proBNP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nt-proBNP guided dischargeOther
Every patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. The cutoff point of 30% reduction in NTproBNP was chosen based on previous studies
| Study group | Role | What they receive |
|---|---|---|
| Usual | No intervention | Every patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged according to routine clinical practice based on symptoms, physical examination and other data that the cardiologist deems appropriate, except for Nt-proBNP. |
| Nt-proBNP guided | Experimental | Every patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. The cutoff point of 30% reduction in NTproBNP was chosen based on previous studies Receives: Other: Nt-proBNP guided discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of hospitalization
Measured: At the index episode (at discharge)
Secondary outcomes (1)
Death or readmission by heart failure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionMar 2013
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.
- More trials run by University of ValenciaThe 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Sanchis, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299350
- Sponsor's protocol ID
- University of Valencia
- Status last verified
- Apr 2014
- First submitted
- 17 Feb 2011
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between Nt-proBNP or Clinical Guided Discharges in Patients Hospitalized With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT01299350
- Acronym / sponsor ID
- University of Valencia
- Conditions
- Heart Failure
- Keywords
- Heart failure, Nt-proBNP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Feb 2011 (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.
Our objective is to compare a policy of hospital discharge guided by NT-proBNP levels versus discharge guided by conventional clinical criteria, in patients admitted with acute heart failure. The hypothesis is that the Nt-proBNP guided discharge will shorten hospital stay without worsening the outcome
Detailed description
Nt-proBNP levels as well as their response to pharmacological treatment are predictive of prognosis in patients with heart failure. The purpose of the present project is to investigate, in patients hospitalized with acute heart failure, whether a discharge decision guided by Nt-proBNP response shortens hospital stay and improves prognosis The included patients will be randomly assigned to one of these two strategies: hospital discharge according to clinical conventional criteria or discharge guided by Nt-proBNP. All patients will be treated following clinical guidelines. In the guided Nt-proBNP strategy, patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. In the conventional strategy, patients will be discharged at criterion of the attending cardiologist according to clinical assessment without Nt-proBNP. The main outcome will be the number of days of hospitalization at the index episode, and the secondary outcome will be death or readmission by heart failure at one and 6 months. Our hypothesis is that the Nt-proBNP guided discharge will allow to precisely evaluate the response to treatment and to determine the best time for hospital discharge. This will reduce hospital stay and death or readmission rate after discharge.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual | No intervention | –Every patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged according to routine clinical practice based on symptoms, physical examination and other data that the cardiologist deems appropriate, except for Nt-proBNP. |
| Nt-proBNP guided | Experimental | Other: Nt-proBNP guided dischargeEvery patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. The cutoff point of 30% reduction in NTproBNP was chosen based on previous studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical signs and symptoms of acute heart failure, according to the criteria of the European guidelines
- NT-proBNP levels > 1000 pg/ml at the time of admission
- age over 18 years old
- signed informed consent
Key exclusion criteria (6 listed)
- GFR less than 30 ml/minute/m2,
- life expectancy as determined by concomitant diseases under one year,
- acute coronary syndrome within 10 days prior,
- valvular heart disease with surgical approach,
- infection or process active malignancy,
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 |
|---|---|---|
| Nt-proBNP guided dischargeEvery patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. The cutoff point of 30% reduction in NTproBNP was chosen based on previous studies | Other | Nt-proBNP guided |
Primary outcome
Days of hospitalization
Time frame: At the index episode (at discharge)
1 secondary outcome
Death or readmission by heart failure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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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 Phase 4 study testing Nt-proBNP guided discharge in people with Heart Failure, run by University of Valencia at 1 site in Spain.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Apr 2014. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Days of hospitalization (time frame: At the index episode (at discharge)). 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 10 Apr 2014.