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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite of all-cause mortality plus acute heart failure related rehospitalization
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación para la Investigación del Hospital Clínico de Valencia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministerio de Sanidad, Servicios Sociales e Igualdad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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