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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013727
Receipt No. R000016028
Scientific Title Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Date of disclosure of the study information 2014/04/16
Last modified on 2018/04/19

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Basic information
Public title Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Acronym Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Scientific Title Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Scientific Title:Acronym Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Region
Japan

Condition
Condition acute decompensated heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction using cardiac sympathetic nerve activity as an indicator
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes H/M MIBG uptake ratio on the delayed images,
Changes in washout rate of cardiac MIBG
Key secondary outcomes 1)blood biomarkers: vasopressin, three fractions of catecholamine, renin activity, aldosterone levels and serum osmolality
2)urinary biomarker: urinary albumin, urine beta2-microglobulin, urinary L-FABP and urine osmolality
3) Transthoracic echocardiography: LVEF, LVDd/Ds, E/e', LAD
4) Holter electrocardiogram: (TWA, HRV, HRT)
5) arrhythmia
6) cardiovascular event
7) acute kidney injury

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Conventional therapy group
Interventions/Control_2 Tolvaptan add-on therapy group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with left ventricular ejection fraction>=45%
2) Patients with at least one sign of congestion (edema, pulmonary congestion, pleural effusion, jugular venous distention, orthopnea)
3)Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria 1) Patients with hypernatremia (Na>147mEq/L)
2) Patients who do not need diuretic therapy because of dehydration
3) Patients with cardiovascular shock
4) Patients with anuria or patients under hemodialysis
5) Patients with acute coronary syndrome
6) Patients with insensitivity to thirst or difficulty in water intake
7) Patients who need mechanical circulatory assist device (IABP・PCPS)
8) Patients with malignant tumor
9) Patients who need temporary pacing because of bradycardia
10) Patients who were judged inappropriate by the principal investigator
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Tamaki
Organization Osaka General Medical Center
Division name Department of Cardiology
Zip code
Address 3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Email kenkyusien@gh.opho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Tamaki
Organization Osaka General Medical Center
Division name Department of Cardiology
Zip code
Address 3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Homepage URL
Email kenkyusien@gh.opho.jp

Sponsor
Institute Osaka General Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 16 Day
Last modified on
2018 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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