Ensayo aleatorio sobre el tratamiento farmacológico de la insuficiencia cardiaca aguda mediante en control de un marcador biológico (CA 125) después del alta hospitalaria

Conditions: acute heart failure
MedDRA version: 14.1Level: PTClassification code 10007556Term: Cardiac failure acuteSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-000414-20-ES

Lead Sponsor: Consorcio de Apoyo a la Investigacion Biomedica en Red (CAIBER)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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<50%); left ventricular hypertrophy (defined as LVM index > 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

1. Serum CA125 value ?35 U/ml evaluated at hospital discharge.
2. Life expectancy <12 months due to other diseases different from HF.
3. Having undergone a cardiac transplantation, coronary revascularization procedure (percutaneous coronary intervention and/or coronary artery bypass grafting) or cardiac valve replacement in the past 3 months.
4. Angina pectoris higher than class II (Canadian Cardiovascular Society Classification).
5. Pregnancy at the moment of enrollment.
6. Valvular heart disease already scheduled for surgical intervention.
7. Severe chronic obstructive and/or restrictive pulmonary disease, requiring continuous oxygen administration.
8. Serum creatinine level > 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.