Efficacy and Safety of Tolvaptan in Japanese Patients With Acute Heart Failure (MT FUJI)

This study is currently recruiting participants.
Verified March 2014 by Translational Research Informatics Center, Kobe, Hyogo, Japan
Sponsor:
Collaborator:
Nippon Medical School, Musashi Kosugi Hospital
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT01635517
First received: July 3, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Tolvaptan Study For Uncontrolled Volume Overload in Japanese Acute Decompensated Heart faIlure Patients: A Prospective Observational Multicenter Cohort Study

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Efficacy 1) Alleviation of the signs of body fluid retention 2) Change of body weight 3) Changes in the daily urinary volume [ Time Frame: At the day of discontinuation of tolvaptan or day 7, whichever comes first ] [ Designated as safety issue: No ]
    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

  • Safety: adverse events Adverse events until 30 days after the end of treatment with tolvaptan [ Time Frame: 30 days after tolvaptan withdrawal ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 1 year after administration of tolvaptan ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • 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 [ Time Frame: 1 year after administration of tolvaptan ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tolvaptan
Tolvaptan administration

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635517

Contacts
Contact: Naoki Sato, MD,PhD +81-44-733-5181 nms-ns@nms.ac.jp

Locations
Japan
Nippon Medical School, Musashi Kosugi Hospital Recruiting
Kawasaki, Kanagawa, Japan, 211-8533
Contact: Naoki Sato, MD, PhD    +81-44-733-5181    nms-ns@nms.ac.jp   
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Nippon Medical School, Musashi Kosugi Hospital
Investigators
Principal Investigator: Naoki Sato, MD,PhD Nippon Medical School, Musashi Kosugi Hospital
  More Information

No publications provided

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01635517     History of Changes
Other Study ID Numbers: TRIHF1203, UMIN000008258
Study First Received: July 3, 2012
Last Updated: March 5, 2014
Health Authority: Japan: Institutional Review Board, Nippon Medical School, Musashi Kosugi Hospital

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Diuretics
Vasopressins
Sodium

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014