Status:
COMPLETED
Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure
Lead Sponsor:
The Christ Hospital
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
For patients hospitalized with acute decompensated heart failure,volume removal remains the primary therapeutic objective. The current standard of care remains loop diuretics.The high likelihood of re...
Detailed Description
Study design is a prospective randomized open labeled and unblinded comparison of two different approaches to volume removal. Enrolled patients will be evaluated for target weight to be removed. Patie...
Eligibility Criteria
Inclusion
- 2 of 3 physical exam findings of volume overload (rales, JVP over 5 cm and edema)
- BNP over 300
- no contraindication to ultrafiltration (line insertion, heparin use)
Exclusion
- serum creatinine \> 3mg/dL or Na \> 145
- inotrope or vasopressor dependency
- active infection, including urinary tract
- resynchronization therapy or coronary intervention in past 30 days
- life expectancy less than 6 months
- hypertrophic obstructive cardiomyopathy with peak resting gradient \> 20 mmHg
- IV contrast or NSAID use in the past 1 week (uNGAL related requirement)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01863511
Start Date
May 1 2013
End Date
December 1 2015
Last Update
January 28 2016
Active Locations (1)
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1
The Christ Hospital
Cincinnati, Ohio, United States, 45011