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Clinical Trials/EUCTR2014-001433-83-ES
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.

Registry
who.int
Start Date
October 16, 2014
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundación INCLIVA

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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