UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011807 |
|---|---|
| Receipt number | 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 10:17:02 |
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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
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
tanakah@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013804
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