Back to resultsCarbohydrate Antigen 125-guided Therapy in Heart Failure (CHANCE-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
CA125 guided strategy
CA125 guided strategy
CA125 guided strategy
CA125 guided strategy
Standard treatment strategy
CA125 guided strategy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Biomarker guided-therapy, Carbohydrate antigen 125, Clinical outcomes.
Eligibility Criteria
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.
Sites / Locations
- Hospital Clínico Unbiversitario de Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CA125 guided strategy
Standard treatment strategy
Arm Description
In this group, physician will be encouraged to maximize all treatment measures aimed to keep CA125≤35 U/ml (normal values).
Therapy is based on established european current guidelines
Outcomes
Primary Outcome Measures
Composite of all-cause mortality plus acute heart failure related rehospitalization
Secondary Outcome Measures
Composite of total mortality plus readmission for any cause
Days alive outside of the hospital
Number of heart failure rehospitalizations.
Number of episodes of worsening HF not requiring hospitalization
Full Information
NCT ID
NCT02008110
First Posted
December 7, 2013
Last Updated
February 3, 2016
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators
Ministerio de Sanidad, Servicios Sociales e Igualdad
1. Study Identification
Unique Protocol Identification Number
NCT02008110
Brief Title
Carbohydrate Antigen 125-guided Therapy in Heart Failure
Acronym
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).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators
Ministerio de Sanidad, Servicios Sociales e Igualdad
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Biomarker guided-therapy, Carbohydrate antigen 125, Clinical outcomes.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CA125 guided strategy
Arm Type
Experimental
Arm Description
In this group, physician will be encouraged to maximize all treatment measures aimed to keep CA125≤35 U/ml (normal values).
Arm Title
Standard treatment strategy
Arm Type
Active Comparator
Arm Description
Therapy is based on established european current guidelines
Intervention Type
Drug
Intervention Name(s)
CA125 guided strategy
Intervention Description
Up titration of loop diuretics according to plasma levels of CA125 in the active arm
Intervention Type
Drug
Intervention Name(s)
CA125 guided strategy
Intervention Description
Consider statins in all patients in the active arm
Intervention Type
Drug
Intervention Name(s)
CA125 guided strategy
Intervention Description
Consider omega-3 polyunsaturated fatty acids in the active arm
Intervention Type
Other
Intervention Name(s)
CA125 guided strategy
Intervention Description
Frequency of monitoring according plasma evolution of CA125 in the active arm.
Intervention Type
Drug
Intervention Name(s)
Standard treatment strategy
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
CA125 guided strategy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Composite of all-cause mortality plus acute heart failure related rehospitalization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Composite of total mortality plus readmission for any cause
Time Frame
1 year
Title
Days alive outside of the hospital
Time Frame
1 year
Title
Number of heart failure rehospitalizations.
Time Frame
1 year
Title
Number of episodes of worsening HF not requiring hospitalization
Time Frame
1-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Núñez, MD, PhD
Organizational Affiliation
Fundación para la Investigación del Hospital Clínico de Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Unbiversitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
27522630
Citation
Nunez J, Llacer P, Bertomeu-Gonzalez V, Bosch MJ, Merlos P, Garcia-Blas S, Montagud V, Bodi V, Bertomeu-Martinez V, Pedrosa V, Mendizabal A, Cordero A, Gallego J, Palau P, Minana G, Santas E, Morell S, Llacer A, Chorro FJ, Sanchis J, Facila L; CHANCE-HF Investigators. Carbohydrate Antigen-125-Guided Therapy in Acute Heart Failure: CHANCE-HF: A Randomized Study. JACC Heart Fail. 2016 Nov;4(11):833-843. doi: 10.1016/j.jchf.2016.06.007. Epub 2016 Aug 10.
Results Reference
derived
PubMed Identifier
25623430
Citation
Nunez J, Merlos P, Facila L, Llacer P, Bosch MJ, Bertomeu-Martinez V, Garcia-Blas S, Montagud V, Pedrosa V, Mendizabal A, Cordero A, Minana G, Sanchis J, Bertomeu-Gonzalez V; CHANCE-HF Investigators. Prognostic effect of carbohydrate antigen 125-guided therapy in patients recently discharged for acute heart failure (CHANCE-HF). Study design. Rev Esp Cardiol (Engl Ed). 2015 Feb;68(2):121-8. doi: 10.1016/j.rec.2014.03.018. Epub 2014 Aug 10.
Results Reference
derived
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Carbohydrate Antigen 125-guided Therapy in Heart Failure
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