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Completed

NCT Number: NCT01635517

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Medical School, Musashi Kosugi Hospital

Kawasaki, Kanagawa, 211-8533, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

    • 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

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

    Time frame: 30 days after tolvaptan withdrawal

  3. 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

    • 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 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

    Time frame: 1 year after administration of tolvaptan

    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.

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Nippon Medical School, Musashi Kosugi Hospital

Registry information

Official study title

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

Acronym: MT FUJI

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2012
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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