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NT-proBNP in the Management of Discharged Patients With Acutely Decompensated Heart Failure and Preserved Ejection Fraction

Primary Purpose

Heart Failure, Preserved Left Ventricular Ejection Fraction

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
NT-proBNP (Cardiac Biomarkers)
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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

  2. -Administration of at least 40 mg IV furosemide (or equivalent) at admission
  3. -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)
  4. -Ability to sign the informed consent

Exclusion Criteria:

  1. Significant lung disease demonstrated by spirometry
  2. Life´s prognosis < 6 months
  3. Patients who does not have adhesion at the different visits of the study

Sites / Locations

  • Hospital Virgen de La Arrixaca

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Usual care plus NT-proBNP

Arm Description

Control Group

Experimental Group

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
June 3, 2016
Last Updated
August 7, 2019
Sponsor
Hospital Universitario Virgen de la Arrixaca
Collaborators
Juan Cinca Cuscullola, Pablo García Pavía, Manuel Martinez Selles, Antoni Bayés Genís, Alfonso Varela Román, Pedro Luis Sánchez Fernández
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1. Study Identification

Unique Protocol Identification Number
NCT02807168
Brief Title
NT-proBNP in the Management of Discharged Patients With Acutely Decompensated Heart Failure and Preserved Ejection Fraction
Official Title
NT-proBNP in the Management of Discharged Patients With Acutely Decompensated Heart Failure and Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca
Collaborators
Juan Cinca Cuscullola, Pablo García Pavía, Manuel Martinez Selles, Antoni Bayés Genís, Alfonso Varela Román, Pedro Luis Sánchez Fernández

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Preserved Left Ventricular Ejection Fraction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Control Group
Arm Title
Usual care plus NT-proBNP
Arm Type
Experimental
Arm Description
Experimental Group
Intervention Type
Other
Intervention Name(s)
NT-proBNP (Cardiac Biomarkers)
Primary Outcome Measure Information:
Title
Decrease of rehospitalizations due to acute heart failure at 6 months after discharge.
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 -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 Exclusion Criteria: Significant lung disease demonstrated by spirometry Life´s prognosis < 6 months Patients who does not have adhesion at the different visits of the study
Facility Information:
Facility Name
Hospital Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

NT-proBNP in the Management of Discharged Patients With Acutely Decompensated Heart Failure and Preserved Ejection Fraction

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