Clinical trial NCT01635517: Efficacy and Safety of Tolvaptan in Japanese Patients With Acute Heart Failure
Official title: Multicenter Tolvaptan Study For Uncontrolled Volume Overload in Japanese Acute Decompensated Heart faIlure Patients: A Prospective Observational Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Diuretics
Vasopressins
Sodium
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Nippon Medical School, Musashi Kosugi Hospital
First posted: 2012-07-09
Enrollment: 274
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for decompensated heart failure with fluid retention and serum sodium levels of less than 140 mEq/L

Brief summary: The aims of the present study are to investigate prospectively the clinical course and outcome of the hospitalized heart failure patients treated with tolvaptan for management of fluid retention and serum sodium levels of less than 140 mEq/L and also to analyze the factors related with the efficacy including outcome of tolvaptan therapy.

Detailed description: Vasopressin mediates fluid retention in heart failure. Tolvaptan, an oral, nonpeptide, selective vasopressin V2-receptor antagonist, shows promise for management of heart failure.

Eligibility criteria: Inclusion Criteria:

1. hospitalized patients for decompensated heart failure with signs of fluid retention despite using diuretics other than tolvaptan and planned tolvaptan use
2. serum Na \< 140 mEq/L
3. age: \> or = 20 years at the time of informed consent
4. provided written informed consent.

Exclusion Criteria:

1. hemodynamic instability
2. patients with hypersensitivity to tolvaptan or similar compounds
3. anuric patients
4. patients who cannot feel thirst and are difficult to intake the fluid
5. patients who are pregnant, potentially pregnant or willing to be pregnant
6. patients have taken tolvaptan before enrollment after hospitalization
7. acute coronary syndrome
8. adrenal insufficiency
9. patients scheduled to undergo coronary angioplasty within the study period
10. ineligible patients according to the investigator's judgment

Primary outcomes:
measure: Efficacy 1) Alleviation of the signs of body fluid retention 2) Change of body weight 3) Changes in the daily urinary volume
timeFrame: At the day of discontinuation of tolvaptan or day 7, whichever comes first
measure: Safety: adverse events Adverse events until 30 days after the end of treatment with tolvaptan
timeFrame: 30 days after tolvaptan withdrawal
measure: Long-term outcome (1 year after tolvaptan administration) 1) Time from enrollment to cardiovascular events 2) Time from enrollment to re-hospitalization for aggravation of heart failure 3) Time from enrollment to all-cause death
timeFrame: 1 year after administration of tolvaptan
Secondary outcomes:
measure: Search for the factors related with the efficacy of tolvaptan therapy and long-term outcome 1) related factors regarding efficacy of tolvaptan 2 ) related factors regarding long-term outcome
timeFrame: 1 year after administration of tolvaptan
Other outcomes:
Locations:
city: Kawasaki
country: Japan
facility: Nippon Medical School, Musashi Kosugi Hospital
state: Kanagawa
Study officials:
affiliation: Nippon Medical School, Musashi Kosugi Hospital
name: Naoki Sato, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: