Carbohydrate Antigen 125-guided Therapy in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CA125 guided strategy

In this group, physician will be encouraged to maximize all treatment measures aimed to keep CA125≤35 U/ml (normal values).

Group Type EXPERIMENTAL

CA125 guided strategy

Intervention Type DRUG

Up titration of loop diuretics according to plasma levels of CA125 in the active arm

CA125 guided strategy

Intervention Type DRUG

Consider statins in all patients in the active arm

CA125 guided strategy

Intervention Type DRUG

Consider omega-3 polyunsaturated fatty acids in the active arm

CA125 guided strategy

Intervention Type OTHER

Frequency of monitoring according plasma evolution of CA125 in the active arm.

CA125 guided strategy

Intervention Type DRUG

All patients should be treated following standard european guidelines regarding angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, ivabradine and other treatments such as (diet, anticoagulants, antiarrhythmics, digoxin, nitrates and vasoactive group).

Standard treatment strategy

Therapy is based on established european current guidelines

Group Type ACTIVE_COMPARATOR

Standard treatment strategy

Intervention Type DRUG

All patients should be treated following standard european guidelines regarding angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, aldosterone antagonists, diuretics, ivabradine and other treatments such as (diet, anticoagulants, antiarrhythmics, statins, omega-3 polyunsaturated fatty acids, digoxin, nitrates and vasoactive group).

Interventions

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CA125 guided strategy

Up titration of loop diuretics according to plasma levels of CA125 in the active arm

Intervention Type DRUG

CA125 guided strategy

Consider statins in all patients in the active arm

Intervention Type DRUG

CA125 guided strategy

Consider omega-3 polyunsaturated fatty acids in the active arm

Intervention Type DRUG

CA125 guided strategy

Frequency of monitoring according plasma evolution of CA125 in the active arm.

Intervention Type OTHER

Standard treatment strategy

All patients should be treated following standard european guidelines regarding angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, aldosterone antagonists, diuretics, ivabradine and other treatments such as (diet, anticoagulants, antiarrhythmics, statins, omega-3 polyunsaturated fatty acids, digoxin, nitrates and vasoactive group).

Intervention Type DRUG

CA125 guided strategy

All patients should be treated following standard european guidelines regarding angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, ivabradine and other treatments such as (diet, anticoagulants, antiarrhythmics, digoxin, nitrates and vasoactive group).

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No