acute heart failure MedDRA version: 14.1 Level: PT Classification code 10007556 Term: Cardiac failure acute System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: Furosemide
Product Code: Furosemide
Pharmaceutical Form: Tablet
CAS Number: 54-31-9
Current Sponsor code: Furosemide
Other descriptive name: Furosemide
Concentration unit: mg milligram(s
Sponsors
Consorcio de Apoyo a la Investigacion Biomedica en Red (CAIBER)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older. 2. At least 1 admission for acute HF, in the last 180 days. 3. Demonstrates functional NYHA status of Class II, or III at the moment of enrollment. 4. Objective evidence, either during the index admission or at least 180 days before enrollment, of a structural or functional abnormality of the heart at rest, and defined as: 4.1. NT-proBNP >1000 pg/ml or BNP>100 pg/ml and, 4.2. Echocardiographic abnormalities congruent with HF diagnosis such as: systolic left ventricular dysfunction (LVEF 104 g/m2 in women or 116 g/m2 in men) or Ee`>15. 5. A CA125 value >35 U/ml in a recent test evaluation (at least 7 days before enrollment, and preferably assessed at hospital discharge). 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 252
Exclusion criteria
Exclusion criteria: 1. Serum CA125 value ?35 U/ml evaluated at hospital discharge. 2. Life expectancy 3 mg/dl or chronic renal insufficiency being treated with dialysis treatment. 9. Patients receiving resynchronization therapy during the index admission. 10. Significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the screening period, endometriosis, cirrhosis, acute coronary syndrome within 6 months, uncontrolled hypertension, history of human immunodeficiency virus (HIV) infection, or a significant active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the effect on 1-year all-cause mortality between intensive medical treatment (guided by the plasma values of CA125) with usual care in patients recently hospitalized for AHF (<180 days).;Secondary Objective: Secondary objectives are based on the comparison between both strategies (CA125 guided management therapy vs. usual care) in terms of: 1. One-year composite of total mortality and readmission for any cause at 1-year. 2. Days alive outside of the hospital at 1-year. 3. Number of AHF hospitalizations at 1-year. 4. Number of episodes of HF decompensation not requiring hospitalization at 1-year. 5. Percent of patients who normalize CA125 values (?35 U/ml) and time to achieve such goal. 6. Effects on levels of standard inflammatory markers (at 1, 6 and 12 months). 7. Effects on BNP/NT-proBNP levels (at 1, 6 and 12 months).;Primary end point(s): The proportion of patients alive at 1 year;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with the composite endpoint of mortality and/or rehospitalization at 1 year. Proportion of patients alive and out of the hospital at 1 year The frequency and proportion of rehospitalizations at 1 year. Primary Biomarker Efficacy Endpoint: change in CA125 serum levels over 1 year, and its relation with the treatment received. BNP/NT-proBNP efficacy endpoint: change in BNP/NT-proBNP levels over 1 year, and its relation with concomitant measurements of CA125, with treatment received and patient clinical status.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactConsorcio de Apoyo a la Investigaci
Consorcio de Apoyo a la Investigacion Biomedica en Red (CAIBER)
Outcome results
None listed