Carbohydrate Antigen 125-guided Therapy in Heart Failure (CHANCE-HF)

Fundación para la Investigación del Hospital Clínico de Valencia

Status and phase

Completed

Phase 4

Conditions

Heart Failure

Treatments

Drug: Standard treatment strategy

Drug: CA125 guided strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT02008110

EC10-108

2011-000414-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.