Hypertensive Left Ventricular HypertrophyPhase 4EARTHNCT01893788
Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy
A Phase 4 study testing Aliskiren and Eplerenone in people with Hypertensive Left Ventricular Hypertrophy, run by Nagoya University at 1 site in Japan.
Trial summary
The primary objective of this study is to determine which treatment will be more effective to reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy comparing aliskiren and eplerenone. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertensive Left Ventricular Hypertrophy
- What is being tested?
- Aliskiren and Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2013to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≧ 20 years of age Clinical diagnosis of hypertension Patients who are able to provide written informed consent
Who cannot join
- History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
- Planned to taking percutaneous coronary intervention and coronary artery bypass graft
- Severe hypertension (≧ 180/110 mmHg) or secondary hypertension or malignant hypertension.
- History of stroke, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack in the recent 6 months
- Severe valvular heart disease or atrial fibrillation
- Congenital heart disease
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- Severe heart failure (NYHA functional class Ⅳ)
- Current treatment with aliskiren or eplerenone or diuretics
- Taking potassium preparation or potassium-sparing diuretic
- Estimated GFR ≦ 30ml/min/1.73m２ at screening or current treatment with hemodialysis
- Potassium > 5.0mEq/L at screening
- Diabetes mellitus with microalbuminuria or albuminuria
- Impairment of liver function (liver failure, liver cirrhosis)
- Pregnant woman or possibly pregnant woman
- History of malignant tumor include hematological neoplasm
- Current treatment with itraconazole, cyclosporin, ritonavir or nelfinavir
- Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren and/or eplerenone
- Current participation in another clinical trial
- Serious non-cardiovascular disease severely limiting life expectancy
- Contra-indication to MRI
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Cardiology, Nagoya University Graduate School of Medicine
Nagoya, Aichi-ken, 466-8550
Takanori Nagahiro, MD, 81-52-744-2149, t-nagahiro@med.nagoya-u.ac.jp
Toyoaki Murohara, MD, PhD, 81-52-744-2149, murohara@med.nagoya-u.ac.jp
About this study
The primary objective of this study is to determine which treatment will be more effective to reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy comparing aliskiren and eplerenone.
- Being tested
- Aliskiren, Eplerenone
- Keywords
- hypertension, left ventricular hypertrophy, renin angiotensin system, aldosterone, aliskiren, eplerenone, P3NP
- Medical subject headings
- Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Rasilez
Aliskiren: 150 to 300 mg daily for 48 weeks
EplerenoneDrug
Also called Selara
50 to 100 mg daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Active comparator | Aliskiren group treated with 150-300mg daily aliskiren without diuretics or ACE inhibitors or angiotensin receptor blockers. Receives: Drug: Aliskiren |
| Eplerenone | Active comparator | Eplerenone group treated with 50-100mg daily eplerenone without diuretics or ACE inhibitors or angiotensin receptor blockers Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of left ventricular hypertrophy measured by magnetic resonance imaging
To compare the 12 month left ventricular mass or left ventricular mass and index measured by magnetic resonance imaging with baseline.
Measured: 12 month
Secondary outcomes (1)
Cardiovascular events
total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Left Ventricular HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOYOAKI MUROHARA, Nagoya University
- Investigators
- Toyoaki Murohara, MD, PhD, Principal investigator, Department of Cardiology, Nagoya University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893788
- Sponsor's protocol ID
- Nagoya University
- Acronym
- EARTH
- Status last verified
- Jul 2013
- First submitted
- 30 Apr 2013
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy
- ClinicalTrials.gov ID
- NCT01893788
- Acronym / sponsor ID
- EARTH / Nagoya University
- Keywords
- hypertension, left ventricular hypertrophy, renin angiotensin system, aldosterone, aliskiren, eplerenone, P3NP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (estimated)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine which treatment will be more effective to reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy comparing aliskiren and eplerenone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren | Active comparator | Drug: AliskirenAliskiren group treated with 150-300mg daily aliskiren without diuretics or ACE inhibitors or angiotensin receptor blockers. |
| Eplerenone | Active comparator | Drug: EplerenoneEplerenone group treated with 50-100mg daily eplerenone without diuretics or ACE inhibitors or angiotensin receptor blockers |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female ≧ 20 years of age Clinical diagnosis of hypertension Patients who are able to provide written informed consent
Key exclusion criteria (20 listed)
- History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
- Planned to taking percutaneous coronary intervention and coronary artery bypass graft
- Severe hypertension (≧ 180/110 mmHg) or secondary hypertension or malignant hypertension.
- History of stroke, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack in the recent 6 months
- Severe valvular heart disease or atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AliskirenAlso: RasilezAliskiren: 150 to 300 mg daily for 48 weeks | Drug | Aliskiren |
| EplerenoneAlso: Selara50 to 100 mg daily for 48 weeks | Drug | Eplerenone |
Primary outcome
reduction of left ventricular hypertrophy measured by magnetic resonance imaging
Time frame: 12 month
To compare the 12 month left ventricular mass or left ventricular mass and index measured by magnetic resonance imaging with baseline.
1 secondary outcome
Cardiovascular events
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Cardiology, Nagoya University Graduate School of Medicine
Nagoya, Japan
Toyoaki Murohara, MD, PhD principal investigator
Department of Cardiology, Nagoya University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren and Eplerenone in people with Hypertensive Left Ventricular Hypertrophy, run by Nagoya University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of left ventricular hypertrophy measured by magnetic resonance imaging (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2013.