Skip to main content
OpenTrials
Completed

NCT Number: NCT02008110

Carbohydrate Antigen 125-guided Therapy in Heart Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínico Unbiversitario de Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CA125 guided strategy

Drug

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

CA125 guided strategy

Other

Frequency of monitoring according plasma evolution of CA125 in the active arm.

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).

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Composite of total mortality plus readmission for any cause

    Time frame: 1 year

  2. Days alive outside of the hospital

    Time frame: 1 year

  3. Number of heart failure rehospitalizations.

    Time frame: 1 year

  4. Number of episodes of worsening HF not requiring hospitalization

    Time frame: 1-year

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

Registry information

Official study 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).

Acronym: CHANCE-HF

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Dec 11, 2013
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.