Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Christ Hospital
• Treatments: Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Tolvaptan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)