UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011807
Receipt No. R000013804
Scientific Title Effect of Olmesartan on left ventricular diastolic function in patients with chronic heart failure
Date of disclosure of the study information 2013/09/19
Last modified on 2020/04/19 (Ver. 7)

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Basic information
Public title Effect of Olmesartan on left ventricular diastolic function in patients with chronic heart failure
Acronym Olmesartan on diastolic function in patients with chronic heart failure
Scientific Title Effect of Olmesartan on left ventricular diastolic function in patients with chronic heart failure
Scientific Title:Acronym Olmesartan on diastolic function in patients with chronic heart failure
Region
Japan

Condition
Condition chronic heart failure
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study consists of patients with chronic heart failure who treated with ARBs ecept for olmesartan. The purpose of this study is to evaluate the effect of switching from other ARBs to olmesartan on left ventricular diastolic function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Left ventricular diastolic function 6 and 12 months after switching from other ARBs to olmesartan.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Olmesartan
Interventions/Control_2
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with chronic heart failure who treated with ARBs except for olmesartan.
2. Left ventricular systolic dysfunction with ejection fraction<50%
3.Left ventricular diastolic dysfunction with ejection fraction>50%
Key exclusion criteria 1. Hypotension (<90/50 mmHg)
2. Patients with acute coronary syndrome within 3-month, cerebral vascular disturbance, myocarditis, constrictive pericarditis and severe valvular disease.
3. Uncontrolled atrial fibrillation and flutter
4. Chronic kidney disease (Cr>3mg/dl)
5. Pateints with malignancy
6. Renal artery stenosis
7. Patient with pregnancy
8. Allergy of olmesartan
9. Patients who treated with ACEI
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Hidekazu
Middle name
Last name Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code 6500017
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5846
Email tanakah@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Hidekazu
Middle name
Last name Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code 6500017
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5846
Homepage URL
Email tanakah@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
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 Kobe University Hospital Transnational Research Center
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
Tel 078-382-6669
Email chiken@med.kobe-u.ac.jp

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
2013 Year 09 Month 19 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s00380-016-0904-0
Publication of results Published

Result
URL related to results and publications PMID: 27722772 DOI: 10.1007/s00380-016-0904-0
Number of participants that the trial has enrolled 64
Results 
The findings of our study indicate that left ventricular mass index for heart failure patients, who had received other ARBs, significantly decreased 6 months after the change-over to olmesartan despite similar blood pressures and further decreased after 12 months. This reduction tended to be more prominent in patients with left ventricular hypertrophy.
Results date posted
2020 Year 04 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2016 Year 10 Month 08 Day
Baseline Characteristics 
Outpatients with stable heart failure who had been treated with ARBs other than olmesartan
Participant flow 
Outpatient clinic in Kobe University Hospital
Adverse events 
None
Outcome measures 
A change in left ventricular mass index between baseline and 6 months after the start of administration
of olmesartan
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 09 Month 24 Day
Date of IRB
2013 Year 10 Month 16 Day
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
2016 Year 09 Month 22 Day
Date trial data considered complete
2016 Year 09 Month 22 Day
Date analysis concluded
2016 Year 09 Month 22 Day

Other
Other related information

Management information
Registered date
2013 Year 09 Month 19 Day
Last modified on
2020 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=R000013804