Heart Failure Clinical Trial
Official title:
Tolvaptan for the Management of Acute Decompensated Heart Failure in Patients With Advanced or Refractory Heart Failure
Verified date | July 2020 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will clarify the clinical usefulness of Tolvaptan therapy in patients with complicated acute decompensated heart failure and hyponatremia (low blood sodium).
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
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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