Acute Heart Failure MedDRA version: 17.0 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: Furosemida
Product Code: Furosemida
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: FUROSEMIDE
CAS Number: 54-31-9
Other descriptive name: FUROSEMIDE
Product N
Sponsors
Fundación INCLIVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Older than 18 years. 2. Presence of symptoms (dyspnea at rest or minimal exertion) and signs attributable to congestion (signs of congestion on chest radiography or presence of peripheral edema or ascites or jugular engorgement to 45 degrees or crackles on lung auscultation). 3. Elevated natriuretic peptides levels (NT-proBNP >1000 pg/ml or BNP >100 mg/dl). 4. Serum creatinine ?1.4 mg/dl on admission, provided that the estimated glomerular filtration rate is less than 60 ml/min/m2. 5. Intention to be treated with intravenous loop diuretics. 6. Participant or his legal representativeis willing and able to give informed consent for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Life expectancy less than 6 months due to other comorbid conditions. 2. Cardiogenic shock. 3. Diagnosis of acute coronary syndrome in the previous 30 days. 4. Pregnancy at the time of inclusion. 5. Severe obstructive or restrictive lung disease. 6. Previously known Stage V chronic kidney disease (estimated glomerular filtration rate <15 ml/min/m2) or patient included in the dialysis program. 7. Participation in another randomized trial at the time of inclusion. 8. History of malignancy within the last 2-year 5.2.10. Temperature ?38°C or diagnosis of pneumonia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether a dosing strategy of loop diuretics guided by plasma levels of CA125 is superior to a strategy of standard dosage of loop diuretics regarding improving renal function and/or prevent renal deterioration at 24 and 72 hours after admission.;Secondary Objective: 1. Resolution of the breathlessness (changes in New York Heart Association functional class), signs of systemic congestion and patient global assessment (by visual analogue scale VAS) at 24 and 72 hours after admission. 2. Changes in plasma levels of natriuretic peptide (NT-proBNP) and high-sensitivity troponin 72 hours after admission. 3. Reduction of hospital stay and the time required for the passage of intravenous to oral diuretic administration. 4. Changes in systemic bioimpedance 72 hours after admission. 5. Clinical events: combined adverse event of death/rehospitalization for AHF at 30 days. 6. Parameters of renal function (creatinine, urea, NGAL and Cystatin C) at 30 days.;Primary end point(s): The worsening and improvement of renal function is defined as an increase or decrease in the figures of creatinine ?0.3 mg/dl, respectively.;Timepoint(s) of evaluation of this end point: 24 and 72 hours and 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Functional class, defined by the New York Heart Association (NYHA) functional class. 2. The overall assessment of the patient will be assessed by visual analogue scale (VAS). 3. hsTnT and natriuretic peptides will be evaluated using commercial reagents as used in routine clinical practice. 3. Systemic bioimpedance will be assessed at admission and 72 hours using the bioelectrical impedance vector analysis (BIVA). 4. Clinical adverse events considered are death from any cause or readmission for AHF the first 30 days after admission.;Timepoint(s) of evaluation of this end point: 24 and 72 hours and 30 days | — |
Countries
Spain
Contacts
Public ContactMarta Peiro
Fundación INCLIVA
Outcome results
None listed