Carbohydrate Antigen 125-guided Therapy in Heart Failure

NCT02008110 | Completed Phase 4 DMC

• 2 other identifiers: EC10-1082011-000414-20
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; Biomarker guided-therapy; Carbohydrate antigen 125; Clinical outcomes.

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality plus acute heart failure related rehospitalization

  1 year

Secondary Outcomes (4)

• 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

Study Arms (2)

CA125 guided strategy

EXPERIMENTAL

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; Other: CA125 guided strategy

Standard treatment strategy

ACTIVE COMPARATOR

Therapy is based on established european current guidelines

Drug: Standard treatment strategy

Interventions

CA125 guided strategy DRUG

Up titration of loop diuretics according to plasma levels of CA125 in the active arm

CA125 guided strategy

Standard treatment strategy DRUG

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).

Standard treatment strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead
• Ministerio de Sanidad, Servicios Sociales e Igualdad: collaborator

Study Sites (1)

Hospital Clínico Unbiversitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (2)

• 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.

  PMID: 27522630 DERIVED

• 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.

  PMID: 25623430 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Julio Núñez, MD, PhD

  Fundación para la Investigación del Hospital Clínico de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 7, 2013
• First Posted: December 11, 2013
• Study Start: December 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: May 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

ES (1)