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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02959411
Other study ID # REB16-0064
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date October 2016
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tolvaptan
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.
Standard of care diuretic therapy
Usual standard of care diuretic therapy for patients hospitalized with acute decompensated heart failure

Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body weight From randomization to 96 hours after randomization
Secondary Total 96 hour urine output Measured in ml urine From randomization to 96 hours post randomization
Secondary Subjective change in shortness of breath As assessed by a 5 point Likert scale 48 hours after randomization and 96 hours post randomization
Secondary Change in renal function Measured by estimated glomerular filtration rate From randomization to 7 days post randomization
Secondary 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 From randomization to 7 days post randomization
Secondary Change in serum sodium Measured in mmol/L From randomization to 7 days post randomization
Secondary Length of hospitalization Number of days in hospital From hospital admission to 30 days post randomization
Secondary Need for intensive care unit admission Categorical measure (yes/no) From hospital admission to 30 days post randomization
Secondary Need for positive inotropic agent use Categorical measure (yes/no) From randomization to 7 days post randomization
Secondary 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) From randomization to 7 days post randomization
Secondary 30 day cardiovascular death and/or hospitalization Categorical outcome (yes/no) From Randomization to 30 days post randomization
Secondary Clinical markers of congestion Described as total number of the presence of Jugular venous pressure (JVP) level, edema, rales, orthopnea, 3rd heart sound From randomization to 96 hours after randomization
Secondary Change in N-terminal brain natriuretic peptide (NT-pro BNP) Measurement calculated in absolute value of NT-pro-BNP From randomization to 96 hours post randomization compared to baseline
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