Efficacy and Safety of Tolvaptan in Japanese Patients With Acute Heart Failure

Heart Failure Clinical Trial

— MT FUJI  

Official title:

Multicenter Tolvaptan Study For Uncontrolled Volume Overload in Japanese Acute Decompensated Heart faIlure Patients: A Prospective Observational Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635517
• Other study ID #: TRIHF1203
• Secondary ID: UMIN000008258
• Status: Completed
• Phase: N/A
• First received: July 3, 2012
• Last updated: June 1, 2017
• Start date: July 1, 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: June 2017
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Japan	Nippon Medical School, Musashi Kosugi Hospital	Kawasaki	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Nippon Medical School, Musashi Kosugi Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy 1) Alleviation of the signs of body fluid retention 2) Change of body weight 3) Changes in the daily urinary volume	1) Alleviation of the signs of body fluid retention by the 7th day of treatment with tolvaptan (or the day of discontinuation of the drug in cases where tolvaptan treatment has been discontinued before the 7th day) as compared with the observations made on the day before the start of treatment 2) Change of body weight by the 7th day of treatment with tolvaptan as compared with the level measured on the day before the start of treatment 3) Changes in the daily urinary volume by the 7th day of treatment with tolvaptan as compared with the values measured on the day before the start of treatment	At the day of discontinuation of tolvaptan or day 7, whichever comes first
Primary	Safety: adverse events Adverse events until 30 days after the end of treatment with tolvaptan		30 days after tolvaptan withdrawal
Primary	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	1) Time from enrollment to cardiovascular events within 1 year after administration of tolvaptan 2) Time from enrollment to re-hospitalization for aggravation of heart failure within 1 year after administration of tolvaptan 3) Time from enrollment to all-cause death within 1 year after administration of tolvaptan; Cardiovascular events included death from heart failure, death from acute coronary syndrome, death from stroke, sudden death, death of unknown causes, death from other cardiovascular causes, readmission for heart failure, ventricular arrhythmia, acute coronary syndrome, and stroke.	1 year after administration of tolvaptan
Secondary	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	Exploratory analysis will be performed to determine which factors relate with the efficacy of tolvaptan therapy or long-term outcome. Factors will include age, gender, medical past history, medication, NYHA classification, Nohria/Steavenson classification, laboratory data (Na, K, Cl, Albumin, Cr, BUN, AST, ALT, gamma-GTP, LDH, T-Bil, BNP, NT-pro BNP, copeptin, galectin-3,aldosteron,angiotensin II, renin, noradrenaline), heart rate, blood pressure, echocardiography data, intake/urine volume and osmolality.	1 year after administration of tolvaptan