NCT02008110

Carbohydrate Antigen 125-guided Therapy in Heart Failure

A Randomized Controlled Trial of Carbohydrate Antigen 125-guided Therapy Among Patients Recently Discharged for Acute Heart Failure: Effect on 1-year Mortality or Readmission for Acute Heart Failure (CHANCE-HF).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Heart Failure

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-07-01
• Completion: 2015-05-01
• First posted: 2013-12-11
• Last updated: 2016-02-04

Locations

1 site across 1 country: Spain