UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021162 |
|---|---|
| Receipt number | R000024406 |
| Scientific Title | Effects of Long-acting Loop Diuretics in Heart Failure with Reduced Ejection Fraction Patients with Cardiac Resynchronization Therapy |
| Date of disclosure of the study information | 2016/02/23 |
| Last modified on | 2016/03/07 16:39:02 |
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Basic information
Public title
Effects of Long-acting Loop Diuretics in Heart Failure with Reduced Ejection Fraction Patients with Cardiac Resynchronization Therapy
Acronym
Effects of long-acting loop diuretics in heart failure patients with reduced ejection fraction.
Scientific Title
Effects of Long-acting Loop Diuretics in Heart Failure with Reduced Ejection Fraction Patients with Cardiac Resynchronization Therapy
Scientific Title:Acronym
Effects of long-acting loop diuretics in heart failure patients with reduced ejection fraction.
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to address the impact of long-acting loop diuretics on the treatment of heart failure and heart failure-associated arrhythmias in heart failure with reduced ejection fraction patients implanted with a cardiac resynchronization therapy device.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints were the variation of fluid index and thoracic impedance measured by cardiac resynchronization therapy at 6 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
We randomly allocated all patients into 2 groups using the envelope method. We used furosemide as short-acting loop diuretics, whereas azosemide as long-acting loop diuretics.
In the furosemide group, the patients were given furosemide as a first drug for 6 months. Then azosemide as a second treatment were received for additional 6 months. There was no washout period at the crossover time because the patients needed to continue taking some diuretic drugs to relieve their symptoms.
Interventions/Control_2
In the azosemide group, the patients were given azosemide as a first drug for 6 months. And then furosemide as a second treatment were received for additional 6 months. There was no washout period at the crossover time because the patients needed to continue taking some diuretic drugs to relieve their symptoms.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients implanted with a cardiac resynchronization therapy device who had previously taken loop diuretics were enrolled in this study.
Key exclusion criteria
The exclusion criteria were 1) any changes pertaining to medication use within 1 month, 2) patients planning an admission to a hospital within the next 3 month for any reasons, and 3) patients undergoing haemodialysis.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Asami |
Organization
Mitsui memorial hospital
Division name
Cardiology
Zip code
Address
1 Kanda Izumicho, Chiyoda-ku, Tokyo, Japan
TEL
+81-3-3862-9111
asami560725@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Asami |
Organization
Cardiology
Division name
Cardiology
Zip code
Address
1 Kanda Izumicho, Chiyoda-ku, Tokyo, Japan
TEL
+81-3-3862-9111
Homepage URL
asami560725@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiology, Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Mitsui memorial hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 23 | 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
| 2013 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2016 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024406
