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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000414-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Ministerio de Sanidad, Servicios Sociales e Igualdad | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Standard treatment strategy | Active Comparator | Therapy is based on established european current guidelines |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CA125 guided strategy | Drug | Up titration of loop diuretics according to plasma levels of CA125 in the active arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality plus acute heart failure related rehospitalization | 1 year |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio Núñez, MD, PhD | Fundación para la Investigación del Hospital ClÃnico de Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Unbiversitario de Valencia | Valencia | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27522630 | Derived | 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. | |
| 25623430 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| CA125 guided strategy | Drug | Consider statins in all patients in the active arm |
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| CA125 guided strategy | Drug | Consider omega-3 polyunsaturated fatty acids in the active arm |
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| CA125 guided strategy | Other | Frequency of monitoring according plasma evolution of CA125 in the active arm. |
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| 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). |
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| CA125 guided strategy | Drug | 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). |
|
| 1 year |
| Number of episodes of worsening HF not requiring hospitalization | 1-year |
| 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. |