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

February 3, 2016 updated by: Julio Nuñez, Fundación para la Investigación del Hospital Clínico de Valencia

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Hospital Clínico Unbiversitario de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CA125 guided strategy
In this group, physician will be encouraged to maximize all treatment measures aimed to keep CA125≤35 U/ml (normal values).
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: 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).
ACTIVE_COMPARATOR: Standard treatment strategy
Therapy is based on established european current guidelines
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of all-cause mortality plus acute heart failure related rehospitalization
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite of total mortality plus readmission for any cause
Time Frame: 1 year
1 year
Days alive outside of the hospital
Time Frame: 1 year
1 year
Number of heart failure rehospitalizations.
Time Frame: 1 year
1 year
Number of episodes of worsening HF not requiring hospitalization
Time Frame: 1-year
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Collaborators

Ministerio de Sanidad, Servicios Sociales e Igualdad

Investigators

  • Principal Investigator: Julio Nuñez, MD, PhD, Fundación para la Investigación del Hospital Clínico de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

December 7, 2013

First Submitted That Met QC Criteria

December 7, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 3, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC10-108
  • 2011-000414-20 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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