Tolvaptan for Advanced or Refractory Heart Failure

• Status: Terminated
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will clarify the clinical usefulness of Tolvaptan therapy in patients with complicated acute decompensated heart failure and hyponatremia (low blood sodium).

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

Details

• Lead Sponsor: University of Calgary
• Collaborator: Otsuka Canada Pharmaceutical Inc.
• Treatments: Diuretics; Tolvaptan

Criteria

Inclusion Criteria:

• Hospital admission for ADHF with volume overload as evidenced by ≥ 2 of the following:

Elevated JVP, peripheral edema, ascites, pulmonary rales, congestion on chest X-ray, elevated NT-pro-BNP > 2000 pg/ml

• Inadequate clinical response indicated by body weight loss < 1.0 kg/day over 48 hours despite adequate doses of IV loop diuretic (at least 40 mg furosemide daily) and fluid restriction 2 L/24 hours.

• ≥1 of the following over the preceding 48 hours: Potential need for inotropic support to improve urine output, and/or renal insufficiency (estimated glomerular filtration rate <45 mL/min/1.73 m2)

• Serum sodium ≤134 mmol/L

• ≥18 years-old

Exclusion Criteria:

• Cardiac surgery within 60 days of enrollment

• Planned cardiac mechanical support or transplant; subjects with previously implanted ventricular assist device (VAD) will not be excluded

• Need for intravenous pressor support for symptomatic hypotension

• Biventricular pacemaker placement within the last 60 days

• Hemofiltration or dialysis

• Known cirrhosis

• Supine systolic arterial blood pressure less than 85 mmHg

• Refusal or inability to sign informed consent