Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02807168
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2016-06-03
Brief Title:
NT-proBNP in the Management of Discharged Patients With Acutely Decompensated Heart Failure and Preserved Ejection Fraction
Sponsor:
Hospital Universitario Virgen de la Arrixaca
Organization:
Hospital Universitario Virgen de la Arrixaca
Study Overview
Official Title:
NT-proBNP in the Management of Discharged Patients With Acutely Decompensated Heart Failure and Preserved Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 ACCFAHA 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
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 ACCFAHA 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None