Clinical trial NCT02008110: Carbohydrate Antigen 125-guided Therapy in Heart Failure
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart failure
Biomarker guided-therapy
Carbohydrate antigen 125
Clinical outcomes.
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: Ministerio de Sanidad, Servicios Sociales e Igualdad
First posted: 2013-12-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Composite of all-cause mortality plus acute heart failure related rehospitalization
timeFrame: 1 year
Secondary outcomes:
measure: Composite of total mortality plus readmission for any cause
timeFrame: 1 year
measure: Days alive outside of the hospital
timeFrame: 1 year
measure: Number of heart failure rehospitalizations.
timeFrame: 1 year
measure: Number of episodes of worsening HF not requiring hospitalization
timeFrame: 1-year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Unbiversitario de Valencia
Study officials:
affiliation: Fundación para la Investigación del Hospital Clínico de Valencia
name: Julio Núñez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.