MedTrace Logo

Carbohydrate Antigen 125-guided Therapy in Heart Failure

NCT02008110 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2016-02-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CA125 guided strategy

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

DRUG

CA125 guided strategy

Consider statins in all patients in the active arm

DRUG

CA125 guided strategy

Consider omega-3 polyunsaturated fatty acids in the active arm

OTHER

CA125 guided strategy

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

DRUG

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).

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).

Sponsors & Collaborators

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

    collaborator OTHER_GOV

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Principal Investigators

  • Julio Núñez, MD, PhD · Fundación para la Investigación del Hospital Clínico de Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-07-31
Completion
2015-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02008110 on ClinicalTrials.gov