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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000016655
Date of registration:	27/02/2015
Prospective Registration:	No
Primary sponsor:	Tokyo Women's Medical University, Department of Cardiology
Public title:	The effect of tolvaptan in heart failure patients with loop diuretic resistance.
Scientific title:	The effect of tolvaptan in heart failure patients with loop diuretic resistance. - The effect of tolvaptan in heart failure patients with loop diuretic resistance.
Date of first enrolment:	2014/02/27
Target sample size:	50
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018947
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Kentaro Jujo
Address:	8-1, Kawada-cho, Shinjuku-ku, Tokyo Japan
Telephone:	03-3353-8111
Email:	juken1123@mac.com
Affiliation:	Tokyo Women's Medical University Department of cardiology

Name:	Nobuhisa Hagiwara
Address:	8-1, Kawada-cho, Shinjuku-ku, Tokyo Japan
Telephone:	03-3353-8111
Email:	mokayama@hij.twmu.ac.jp
Affiliation:	Tokyo Women's Medical University Department of cardiology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. patients with cardiogenic shock or needs catecholamine or mechanical circulation support 2. intubation 3. obvious bleeding or active gastrointestinal ulceration 4. hemodialysis 5. hyperkalemia (6.0mEq/L) 6. hypernatremia (150mEq/L) 7. hypotension (systolic blood pressure <=85mmHg) or symptomatic hypotension 8. patients who cannot declare thirst or cannot drink water 9. hypersensitivity for Tolvaptan or Mozavaptan 10. expectant mother 11. inappropriate patients judged by the physician in charge

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

heart failure

Intervention(s)

administration of tolvaptan

Primary Outcome(s)

Changes in body weight

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

none

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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