Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure
Completed · Phase 4
Conditions studied: Acute Decompensated Heart Failure
In brief
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 readmissions and poor outcomes highlights the need to examine and improve in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal, less neurohormonal stimulation and greater sodium removal.However it is associated with increased costs, line complications, and relative immobility during treatment. Tolvaptan in addition to diuretic therapy has been shown to improve the amount of volume removed compared to diuretic alone. The study proposes to compare the strategy of adding tolvaptan to usual care with ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients. Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in: * greater volume and weight reduction compared with usual care * similar efficacy outcomes compared with ultrafiltration, with less complications of therapy
Key facts
- Study ID
- NCT01863511
- Run by
- The Christ Hospital
- People needed
- 45
- Starts
- 2013-05-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- The Christ Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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