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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name