Efficacy and Safety of Tolvaptan in Japanese Patients With Acute Heart Failure (MT FUJI)
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|ClinicalTrials.gov Identifier: NCT01635517|
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : June 2, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||274 participants|
|Official Title:||Multicenter Tolvaptan Study For Uncontrolled Volume Overload in Japanese Acute Decompensated Heart faIlure Patients: A Prospective Observational Multicenter Cohort Study|
|Actual Study Start Date :||July 1, 2012|
|Actual Primary Completion Date :||December 31, 2015|
|Actual Study Completion Date :||December 31, 2015|
- 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 ]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 ]
- 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 ]
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635517
|Nippon Medical School, Musashi Kosugi Hospital|
|Kawasaki, Kanagawa, Japan, 211-8533|
|Principal Investigator:||Naoki Sato, MD,PhD||Nippon Medical School, Musashi Kosugi Hospital|