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

NCT01635517 | Completed

• 2 other identifiers: TRIHF1203UMIN000008258
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Diuretics; Vasopressins; Sodium

Outcome Measures

Primary Outcomes (3)

• 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

• Safety: adverse events Adverse events until 30 days after the end of treatment with tolvaptan

  30 days after tolvaptan withdrawal

• 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 Outcomes (1)

• 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

  1 year after administration of tolvaptan

Study Arms (1)

Tolvaptan

Tolvaptan administration

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Nippon Medical School, Musashi Kosugi Hospital: collaborator

Study Sites (1)

Nippon Medical School, Musashi Kosugi Hospital

Kawasaki, Kanagawa, 211-8533, Japan

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Naoki Sato, MD,PhD

  Nippon Medical School, Musashi Kosugi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 9, 2012
• Study Start: July 1, 2012
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: June 2, 2017

Record last verified: 2017-06

Locations

JP (1)