Carbohydrate Antigen 125-guided Therapy in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: CA125 guided strategy
* Drug: CA125 guided strategy
* Drug: CA125 guided strategy
* Other: CA125 guided strategy
* Drug: Standard treatment strategy
* Drug: CA125 guided strategy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CA125 guided strategy<br>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<br>* Up titration of loop diuretics according to plasma levels of CA125 in the active arm<br>Drug: CA125 guided strategy<br>* Consider statins in all patients in the active arm<br>Drug: CA125 guided strategy<br>* Consider omega-3 polyunsaturated fatty acids in the active arm<br>Other: CA125 guided strategy<br>* Frequency of monitoring according plasma evolution of CA125 in the active arm.<br>Drug: CA125 guided strategy<br>* 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).<br>|
| Active Comparator: Standard treatment strategy<br>Therapy is based on established european current guidelines | Drug: Standard treatment strategy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Biomarker guided-therapy, Carbohydrate antigen 125, Clinical outcomes.