oop Diuretics Dosage in Patients with Acute Heart Failure and Renal Failure: Conventional versus Carbohydrate Antigen 125 guided Strategy

Phase 1

• Conditions: Acute Heart Failure; MedDRA version: 17.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001433-83-ES
• Lead Sponsor: Fundación INCLIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-16
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified