Heart FailureNCT02807168
NT-proBNP in the Management of Discharged Patients With Acutely Decompensated Heart Failure and Preserved Ejection Fraction
A study testing NT-proBNP (Cardiac Biomarkers) in people with Heart Failure and Preserved Left Ventricular Ejection Fraction, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Acute decompensated heart failure (ADHF) is a health problem of great magnitude, because it is the most frequent cause of hospitalization of patients over 65 years old. Of these patients, more than 50% will be readmitted within the next six months with the consequent worsening prognosis, increased mortality and high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Preserved Left Ventricular Ejection Fraction
- What is being tested?
- NT-proBNP (Cardiac Biomarkers)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Aug 2019
- 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
- Patients who are discharged after hospitalizations for AHF which is defined by:
- Dyspnea at rest or with minimal effort
- Pulmonary congestion on chest X ray
- NT-pro-BNP levels in the first 24 hours after admission:
- <50 years: >450 pg/ml 50-75 years: >900 pg/mL >75 years: >1800 pg/mL
- -Administration of at least 40 mg IV furosemide (or equivalent) at admission
Show all 13Show fewer
- -Preserved ejection fraction (LVEF>50%) in echocardiography performed at admission and evidence of diastolic dysfunction defined according to following parameters
- e´ <8 cm/s septal or <10 cm/s lateral (TDI mitral annulus)
- E/e' ratio >15
- A mitral-A pulmon > 30 msg
- Left atrial volumen index≥34 mL/m2
- left ventricular mass index >95 g/m2 (woman) o >115 g/m2 (man)
- -Ability to sign the informed consent
Who cannot join
- Significant lung disease demonstrated by spirometry
- Life´s prognosis < 6 months
- Patients who does not have adhesion at the different visits of the study
Trial locations and contacts
1 site in 1 country.
About this study
Acute decompensated heart failure (ADHF) is a health problem of great magnitude, because it is the most frequent cause of hospitalization of patients over 65 years old. Of these patients, more than 50% will be readmitted within the next six months with the consequent worsening prognosis, increased mortality and high costs associated. In fact, two-third parts of the costs of this condition are due to hospitalizations. Hence the increased importance of ADHF and its associated hospitalizations as an essential event in the natural history of the disease on to address therapeutic efforts.
However, at the present time there is a change of scenario that makes that more than half of these patients show HF with preserved ejection fraction (PEF), so that acute heart failure with preserved ejection fraction (AHF-PEF) is a fact with high prevalence and epidemiological relevance. To this the investigators must add that, unlike patients with depressed EF, HF-PEF has no therapeutic strategies that may have proven a recovery of the affected patients. All this makes that overall heart failure with PEF and AHF-PEF represent a major health problem.
Read more
However, despite of the lack of effective treatments, there are also opportunities for improvement both in terms of morbidity and mortality that should be evaluated. Rather than looking for therapies or new specific drugs, these opportunities may be in the use of management strategies among which the use of biomarkers and their monitoring could be key. In this regard, NT-proBNP has been shown to correlate with severity and prognosis, including the risk of decompensation. Nevertheless, whilst the latest guidelines for heart failure management recommend its use in the diagnosis of HF, the use of biomarkers to monitor and guide treatment has not been included yet.
The assumption of this study is that the use of NT-proBNP may serve as a therapeutic and management guideline for the in-patient with HF-PEF who is to be discharged, allowing a reduction of decompensations and hospitalizations as well as a better functional situation at 6 months.
Several criteria have been proposed to define the syndrome of HFpEF according to the 2013 ACCF/AHA Heart Failure Guideline including (a) clinical signs or symptoms of HF; (b) evidence of preserved or normal LVEF; and (c) evidence of abnormal LV diastolic dysfunction that can be determined by Doppler echocardiography or cardiac catheterization The assay N-terminal proB-type natriuretic peptid is indicated as an aid in the diagnosis of individuals suspected of having congestive heart failure and detection of mild forms of cardiac dysfunction. The test also aids in the assessment of heart failure severity in patients diagnosed with congestive heart failure. This assay is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure, and it can also be used for monitoring the treatment in patients with left ventricular dysfunction.
- Being tested
- NT-proBNP (Cardiac Biomarkers)
- 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 (Cardiac Biomarkers)Other
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Control Group |
| Usual care plus NT-proBNP | Experimental | Experimental Group Receives: Other: NT-proBNP (Cardiac Biomarkers) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of rehospitalizations due to acute heart failure at 6 months after discharge.
To assess if a clinical management strategy that includes the monitoring of NT-proBNP concentrations after hospital discharge of patients with AHF-PEF reduces rehospitalizations due to AHF at 6 months after discharge (defined as unplanned hospital admission lasting for at least 24 h and due to HF decompensation).
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 posted21 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionAug 2019
- Study completionAug 2019
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Collaborators
- Juan Cinca Cuscullola, Pablo García Pavía, Manuel Martinez Selles, Antoni Bayés Genís, Alfonso Varela Román, Pedro Luis Sánchez Fernández
- Responsible party
- Principal investigator, Domingo A. Pascual Figal, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807168
- Sponsor's protocol ID
- NICE-preserve
- Status last verified
- Aug 2019
- First submitted
- 3 Jun 2016
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT-proBNP in the Management of Discharged Patients With Acutely Decompensated Heart Failure and Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT02807168
- Acronym / sponsor ID
- NICE-preserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Collaborators
- Juan Cinca Cuscullola, Pablo García Pavía, Manuel Martinez Selles, Antoni Bayés Genís, Alfonso Varela Román, Pedro Luis Sánchez Fernández
- Study start
- Jun 2015
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 21 Jun 2016 (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.
Acute decompensated heart failure (ADHF) is a health problem of great magnitude, because it is the most frequent cause of hospitalization of patients over 65 years old. Of these patients, more than 50% will be readmitted within the next six months with the consequent worsening prognosis, increased mortality and high costs associated. In fact, two-third parts of the costs of this condition are due to hospitalizations. Hence the increased importance of ADHF and its associated hospitalizations as an essential event in the natural history of the disease on to address therapeutic efforts.
However, at the present time there is a change of scenario that makes that more than half of these patients show HF with preserved ejection fraction (PEF), so that acute heart failure with preserved ejection fraction (AHF-PEF) is a fact with high prevalence and epidemiological relevance. To this the investigators must add that, unlike patients with depressed EF, HF-PEF has no therapeutic strategies that may have proven a recovery of the affected patients. All this makes that overall heart failure with PEF and AHF-PEF represent a major health problem.
However, despite of the lack of effective treatments, there are also opportunities for improvement both in terms of morbidity and mortality that should be evaluated. Rather than looking for therapies or new specific drugs, these opportunities may be in the use of management strategies among which the use of biomarkers and their monitoring could be key. In this regard, NT-proBNP has been shown to correlate with severity and prognosis, including the risk of decompensation. Nevertheless, whilst the latest guidelines for heart failure management recommend its use in the diagnosis of HF, the use of biomarkers to monitor and guide treatment has not been included yet.
The assumption of this study is that the use of NT-proBNP may serve as a therapeutic and management guideline for the in-patient with HF-PEF who is to be discharged, allowing a reduction of decompensations and hospitalizations as well as a better functional situation at 6 months.
Several criteria have been proposed to define the syndrome of HFpEF according to the 2013 ACCF/AHA Heart Failure Guideline including (a) clinical signs or symptoms of HF; (b) evidence of preserved or normal LVEF; and (c) evidence of abnormal LV diastolic dysfunction that can be determined by Doppler echocardiography or cardiac catheterization The assay N-terminal proB-type natriuretic peptid is indicated as an aid in the diagnosis of individuals suspected of having congestive heart failure and detection of mild forms of cardiac dysfunction. The test also aids in the assessment of heart failure severity in patients diagnosed with congestive heart failure. This assay is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure, and it can also be used for monitoring the treatment in patients with left ventricular dysfunction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Control Group |
| Usual care plus NT-proBNP | Experimental | Other: NT-proBNP (Cardiac Biomarkers)Experimental Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients who are discharged after hospitalizations for AHF which is defined by:
- <50 years: >450 pg/ml 50-75 years: >900 pg/mL >75 years: >1800 pg/mL
- -Administration of at least 40 mg IV furosemide (or equivalent) at admission
- -Preserved ejection fraction (LVEF>50%) in echocardiography performed at admission and evidence of diastolic dysfunction defined according to following parameters
- -Ability to sign the informed consent
Key exclusion criteria (3 listed)
- Significant lung disease demonstrated by spirometry
- Life´s prognosis < 6 months
- Patients who does not have adhesion at the different visits of the study
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 (Cardiac Biomarkers) | Other | Usual care plus NT-proBNP |
Primary outcome
Decrease of rehospitalizations due to acute heart failure at 6 months after discharge.
Time frame: 6 months
To assess if a clinical management strategy that includes the monitoring of NT-proBNP concentrations after hospital discharge of patients with AHF-PEF reduces rehospitalizations due to AHF at 6 months after discharge (defined as unplanned hospital admission lasting for at least 24 h and due to HF decompensation).
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 9 Aug 2019.
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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 study testing NT-proBNP (Cardiac Biomarkers) in people with Heart Failure and Preserved Left Ventricular Ejection Fraction, run by Hospital Universitario Virgen de la Arrixaca 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 13 inclusion and 3 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 9 Aug 2019. 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.
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?
Decrease of rehospitalizations due to acute heart failure at 6 months after discharge. (time frame: 6 months). 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 9 Aug 2019.