Tolvaptan for Advanced or Refractory Heart Failure (NCT02959411) | Clinical Trial Compass
TerminatedPhase 4
Tolvaptan for Advanced or Refractory Heart Failure
Stopped: Low accrual rate
Canada9 participantsStarted 2016-10
Plain-language summary
This study will clarify the clinical usefulness of Tolvaptan therapy in patients with complicated acute decompensated heart failure and hyponatremia (low blood sodium).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in body weight
Timeframe: From randomization to 96 hours after randomization