A Phase 4 interventional study of Tolvaptan and Standard of care diuretic therapy in Heart Failure and Hyponatremia, sponsored by University of Calgary. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-27.
Sponsored by University of Calgary · Phase 4, Interventional, and Treatment
This study will clarify the clinical usefulness of Tolvaptan therapy in patients with complicated acute decompensated heart failure and hyponatremia (low blood sodium).
Despite its demonstrated efficacy and tolerability, Tolvaptan remains underutilized for the treatment of acute decompensated heart failure (ADHF) in many centers. Post-hoc analysis suggests that Tolvaptan may provide optimal outcomes in patients with more advanced heart failure (HF) including those with cardiorenal syndrome, marked hyponatremia and severe congestion, or a combination of those conditions. The efficacy of Tolvaptan in HF patients with loop diuretic resistance and in those requiring inotropic support remains uncertain.
The purpose of this study is to examine the benefit of Tolvaptan versus the current standard of care diuretic therapy for patients hospitalized with ADHF and evidence of advanced or complex HF with severe hyponatremia. Patients with advanced or complex disease are defined as those with suboptimal diuretic response over a 48 hour period.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 9 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tolvaptan 15-60 mg, once daily for 4 days or until hospital discharge
Drug: Tolvaptan
Usual standard of care diuretic therapy for patients with acute decompensated heart failure
Drug: Standard of care diuretic therapy
Tolvaptan is a selective vasopressin receptor antagonist that inhibits activation of the V2 receptor and synthesis and insertion of the aquaporin2 channel into the apical membrane of the renal collecting duct. Tolvaptan inhibits the reabsorption of free water, inducing free water diuresis and increasing serum sodium levels without adversely influencing electrolyte levels or stimulating the sympathetic nervous system or renin-angiotensin system.
Also known as: Samsca
Usual standard of care diuretic therapy for patients hospitalized with acute decompensated heart failure
Change in body weight
Time frame: From randomization to 96 hours after randomization
Total 96 hour urine output
Measured in ml urine
Time frame: From randomization to 96 hours post randomization
Subjective change in shortness of breath
As assessed by a 5 point Likert scale
Time frame: 48 hours after randomization and 96 hours post randomization
Change in renal function
Measured by estimated glomerular filtration rate
Time frame: From randomization to 7 days post randomization
Proportion of patients developing worsening renal function (WRF)
Categorical measure- need for renal replacement therapy or ultrafiltration or increase in serum creatinine by \> 26 umol/L
Time frame: From randomization to 7 days post randomization
Change in serum sodium
Measured in mmol/L
Time frame: From randomization to 7 days post randomization
Length of hospitalization
Number of days in hospital
Time frame: From hospital admission to 30 days post randomization
Need for intensive care unit admission
Categorical measure (yes/no)
Time frame: From hospital admission to 30 days post randomization
Need for positive inotropic agent use
Categorical measure (yes/no)
Time frame: From randomization to 7 days post randomization
Composite of Worsening Renal Function or need for inotropic agent
Worsening Renal Function defined as increase from serum creatinine at randomization of more than 30 umol/L at any time from randomization to 7 days. This is a categorical outcome (yes/no)
Time frame: From randomization to 7 days post randomization
30 day cardiovascular death and/or hospitalization
Categorical outcome (yes/no)
Time frame: From Randomization to 30 days post randomization
Clinical markers of congestion
Described as total number of the presence of Jugular venous pressure (JVP) level, edema, rales, orthopnea, 3rd heart sound
Time frame: From randomization to 96 hours after randomization
Change in N-terminal brain natriuretic peptide (NT-pro BNP)
Measurement calculated in absolute value of NT-pro-BNP
Time frame: From randomization to 96 hours post randomization compared to baseline
Plan to share: No
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This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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University of Calgary