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Carbohydrate Antigen 125-guided Therapy in Heart Failure (CHANCE-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02008110
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : February 4, 2016
Sponsor:
Collaborator:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Information provided by (Responsible Party):
Julio Nuñez, Fundación para la Investigación del Hospital Clínico de Valencia

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.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: CA125 guided strategy Other: CA125 guided strategy Drug: Standard treatment strategy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CA125 guided strategy
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
Up titration of loop diuretics according to plasma levels of CA125 in the active arm

Drug: CA125 guided strategy
Consider statins in all patients in the active arm

Drug: CA125 guided strategy
Consider omega-3 polyunsaturated fatty acids in the active arm

Other: CA125 guided strategy
Frequency of monitoring according plasma evolution of CA125 in the active arm.

Drug: CA125 guided strategy
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).

Active Comparator: Standard treatment strategy
Therapy is based on established european current guidelines
Drug: Standard treatment strategy
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 Outcome Measures :
  1. Composite of all-cause mortality plus acute heart failure related rehospitalization [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008110


Locations
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Spain
Hospital Clínico Unbiversitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
Ministerio de Sanidad, Servicios Sociales e Igualdad
Investigators
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Principal Investigator: Julio Núñez, MD, PhD Fundación para la Investigación del Hospital Clínico de Valencia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julio Nuñez, MD, PhD, Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT02008110    
Other Study ID Numbers: EC10-108
2011-000414-20 ( EudraCT Number )
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by Julio Nuñez, Fundación para la Investigación del Hospital Clínico de Valencia:
Heart failure
Biomarker guided-therapy
Carbohydrate antigen 125
Clinical outcomes.
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases