Carbohydrate Antigen 125-guided Therapy in Heart Failure

Heart Failure Clinical Trial

— CHANCE-HF  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008110
• Other study ID #: EC10-108
• Secondary ID: 2011-000414-20
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2013
• Last updated: February 3, 2016
• Start date: December 2011
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• CA125 guided strategy
Up titration of loop diuretics according to plasma levels of CA125 in the active arm
• CA125 guided strategy
Consider statins in all patients in the active arm
• 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).
• 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).

Locations

Country	Name	City	State
Spain	Hospital Clínico Unbiversitario de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia	Ministerio de Sanidad, Servicios Sociales e Igualdad

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality plus acute heart failure related rehospitalization		1 year	No
Secondary	Composite of total mortality plus readmission for any cause		1 year	No
Secondary	Days alive outside of the hospital		1 year	No
Secondary	Number of heart failure rehospitalizations.		1 year	No
Secondary	Number of episodes of worsening HF not requiring hospitalization		1-year	No