EUCTR2014-001433-83-ES
Active, not recruiting
Phase 1
oop Diuretics Dosage in Patients with Acute Heart Failure and Renal Failure: Conventional versus Carbohydrate Antigen 125 guided Strategy - IMPROVE-AHF
Fundación INCLIVA0 sites170 target enrollmentOctober 16, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Heart Failure
- Sponsor
- Fundación INCLIVA
- Enrollment
- 170
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Older than 18 years.
- •2\. Presence of symptoms (dyspnea at rest or minimal exertion) and signs attributable to congestion (signs of congestion on chest radiography or presence of peripheral edema or ascites or jugular engorgement to 45 degrees or crackles on lung auscultation).
- •3\. Elevated natriuretic peptides levels (NT\-proBNP \>1000 pg/ml or BNP \>100 mg/dl).
- •4\. Serum creatinine ?1\.4 mg/dl on admission, provided that the estimated glomerular filtration rate is less than 60 ml/min/m2\.
- •5\. Intention to be treated with intravenous loop diuretics.
- •6\. Participant or his legal representativeis willing and able to give informed consent for participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 140
Exclusion Criteria
- •1\. Life expectancy less than 6 months due to other comorbid conditions.
- •2\. Cardiogenic shock.
- •3\. Diagnosis of acute coronary syndrome in the previous 30 days.
- •4\. Pregnancy at the time of inclusion.
- •5\. Severe obstructive or restrictive lung disease.
- •6\. Previously known Stage V chronic kidney disease (estimated glomerular filtration rate \<15 ml/min/m2\) or patient included in the dialysis program.
- •7\. Participation in another randomized trial at the time of inclusion.
- •8\. History of malignancy within the last 2\-year
- •5\.2\.10\. Temperature ?38°C or diagnosis of pneumonia.
Outcomes
Primary Outcomes
Not specified
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