UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006415 |
|---|---|
| Receipt number | R000006054 |
| Scientific Title | The Multicenter Study for Effects of Eplerenone on Cardiac Diastolic Dysfunction in Hypertensive Patients |
| Date of disclosure of the study information | 2011/09/27 |
| Last modified on | 2017/04/03 08:44:10 |
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Basic information
Public title
The Multicenter Study for Effects of Eplerenone on Cardiac Diastolic Dysfunction in Hypertensive Patients
Acronym
The Multicenter Study for Effects of Eplerenone on Cardiac Diastolic Dysfunction in Hypertensive Patients (MELODY STUDY)
Scientific Title
The Multicenter Study for Effects of Eplerenone on Cardiac Diastolic Dysfunction in Hypertensive Patients
Scientific Title:Acronym
The Multicenter Study for Effects of Eplerenone on Cardiac Diastolic Dysfunction in Hypertensive Patients (MELODY STUDY)
Region
| Japan |
Condition
Condition
Hypertensive patients with cardiac diastolic dysfunction and preserved ejection fraction
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of eplerenone on biomarkers of hypertensive patients with cardiac diastolic dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Plasma levels of B-type natriuretic peptide (BNP) from baseline to 12 months of treatment
(if BNP logarithmic transformation does not follow normal distribution, consider using percent changes in BNP from baseline to 12 months of treatment)
Key secondary outcomes
Serum biomarkers
high-sensitive troponin T level, P3NP, hsCRP, Big-endothelin
Urinary biomarkers
urinary albumin, 8-OHdG
Tissue Doppler Echocardiography findings
E, e', E/e'
A composite of hospitalization or death due to cardiovascular event and significant exacerbation of cardio- and cerebro-vascular diseases (at 12 and 24 months from enrollment).
Relationship between onset of cardiovascular event and biomarkers (exploratory)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eplerenone (25-50mg/day) is added to baseline treatment. The dose is adjusted according to conditions of patients with judgement of the physician in charge. Treatment period is for two years. The target blood pressure level is 135/85mmHg.
Interventions/Control_2
Usual treatment without using eplerenone or spilonoractone. The target blood pressure level is 135/85mmHg.
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Ejection Fraction>=50%(The modified simpson method in an echocardiography or Left ventriculography or MRI or RI)
2.High blood pressure with anti-hypertensives)
3.E/e'>=15, or 15>E/e'>=8 and BNP>=100pg/ml (Measurement of E/e' is preferred to use both interventricular septum and side wall, though use of only either one of them is also acceptable complying to the usual method of each institution)
4.No evidence of hospitalization due to heart failure in the past 6 months
Key exclusion criteria
1.Patients with severe renal failure (Ccr<=50ml/mi. Kakuta Y et al. Clin Exp Nephrol. 2010,14(1):63-7.)
2.Serum potassium level is equal or more than 5.0 mEq/L
3.Patients with severe hepatic insufficiency (Child-Pugh Score class C)
4.Patients currently under treatment of Itraconazole, Ritonavir, or Nelfinavir.
5.Patients with hypertrophic obstructive cardiomyopathy, cardiac amyloidosis, cardiac sarcoidosis, connective tissue disease, or malignancy
6.Patients with evere valvular disease
7.Patients with secondary hypertension
8.Patients underwent operative treatment or coronary angioplasty in the past one month
9.Patients treated with eplerenone or spironolactone in the past three months
10.Women who are wising to be pregnant, or of childbearing potential
11.Patients whose physicians determined inadequate to participate the study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Cardiovascular medicine
Zip code
Address
Honjyo 1-1-1, Kumamoto
TEL
0963735175
ogawah@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Yamamuro |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Cardiovascular medicine
Zip code
Address
Honjyo 1-1-1, Kumamoto
TEL
0963735175
Homepage URL
http://www.kumadai-junnai.com/
yamamuro@kumamoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Kumamoto University
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
熊本大学生命科学研究部
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 27 | Day |
Last modified on
| 2017 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006054
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