UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Multicenter Study for Effects of Eplerenone on Cardiac Diastolic Dysfunction in Hypertensive Patients
Title of the study (Brief title)	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	Hisao Ogawa
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Cardiovascular medicine
Address	Honjyo 1-1-1, Kumamoto
TEL	0963735175
Email	ogawah@kumamoto-u.ac.jp

Public contact
Name of contact person	Megumi Yamamuro
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Cardiovascular medicine
Address	Honjyo 1-1-1, Kumamoto
TEL	0963735175
Homepage URL	http://www.kumadai-junnai.com/
Email	yamamuro@kumamoto-u.ac.jp

Sponsor
Institute	Graduate School of Medical Sciences, Kumamoto University
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 02 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006054