A Phase 4 interventional study of CA125 guided strategy and CA125 guided strategy in Heart Failure, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-04.
Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Phase 4, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 360 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 70 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Therapy is based on established european current guidelines
Drug: Standard treatment strategy
Up titration of loop diuretics according to plasma levels of CA125 in the active arm
Consider statins in all patients in the active arm
Consider omega-3 polyunsaturated fatty acids in the active arm
Frequency of monitoring according plasma evolution of CA125 in the active arm.
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).
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).
Composite of all-cause mortality plus acute heart failure related rehospitalization
Time frame: 1 year
Composite of total mortality plus readmission for any cause
Time frame: 1 year
Days alive outside of the hospital
Time frame: 1 year
Number of heart failure rehospitalizations.
Time frame: 1 year
Number of episodes of worsening HF not requiring hospitalization
Time frame: 1-year
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Fundación para la Investigación del Hospital Clínico de Valencia