Carbohydrate Antigen 125-guided Therapy in Heart Failure

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Preliminary data suggest a potential role for monitoring and up-titrate pharmacological therapy of plasma levels of antigen carbohydrate 125 (CA125) following and admission for acute heart failure (AHF).

This study will evaluate the effect of a CA125-guided management strategy versus standard therapy on the composite endpoint of 1-year all-cause mortality or readmission for AHF in patients recently discharged for AHF.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Collaborator: Ministerio de Sanidad, Servicios Sociales e Igualdad
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors

Criteria

Inclusion Criteria:

• Age 18 years or older.

• At least 1 admission for AHF, in the last 180 days.

• Demonstrates functional New York Heart Association status of Class ≥II at the moment of enrollment.

• 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: N terminal-pro-brain natriuretic peptide >1000 pg/ml or brain natriuretic peptide >100 pg/ml or echocardiographic abnormalities congruent with HF diagnosis such as: systolic left ventricular dysfunction (LVEF <50%); left ventricular hypertrophy (defined as left ventricular septum or left ventricular posterior wall thickness ≥12 millimeters or left ventricular mass index >104 g/m2 in women or 116 g/m2 in men); Ee'>15 or significant valvular heart disease (moderate-severe).

• A plasma CA125 value >35 U/ml in a recent test evaluation (at least 30 days before enrollment, and preferably assessed before hospital discharge).

• Patient must be capable of understanding and signing an informed consent form.

Exclusion Criteria:

• Life expectancy <12 months due to other diseases different from HF.

• 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.

• Angina pectoris higher than class II (Canadian Cardiovascular Society Classification).

• Pregnancy at the moment of enrollment.

• Valvular heart disease already scheduled for surgical intervention.

• Severe chronic obstructive and/or restrictive pulmonary disease, requiring continuous oxygen administration.

• Serum creatinine level > 3 mg/dl or chronic renal insufficiency on dialysis treatment.

• Patients receiving resynchronization therapy during the index admission.

• 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.

• Participating in another randomized study.