Myocardial RemodelingAldosteroneNCT00980031
Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension
A study testing Eplerenone and Lactose Tablet in people with Myocardial Remodeling, run by Creighton University at 1 site in United States.
Trial summary
The goal of this project is to investigate the effects that the addition of aldosterone blockade with eplerenone will have on the progression of diastolic dysfunction in patients with controlled essential hypertension. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myocardial Remodeling
- What is being tested?
- Eplerenone and Lactose Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2011
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated and controlled hypertension
- Less than 140/90 in non-diabetics
- Less than 130/80 in diabetics
Who cannot join
- currently receiving an aldosterone blocker
- clinical evidence of congestive heart failure
- prior myocardial infarction
- renal dysfunction with a creatinine clearance of less than 40ml/min
- serum potassium > 5.5meq/L at initiation
- concomitant use of a medication that inhibits the CYP3A4 enzyme (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center (including ambulatory centers)
Omaha, Nebraska, 68131
About this study
The goal of this project is to investigate the effects that the addition of aldosterone blockade with eplerenone will have on the progression of diastolic dysfunction in patients with controlled essential hypertension.
Read the detailed description
The purpose of this project is to determine if eplerenone, an aldosterone blocker, prevents remodelling of the heart in patients with controlled essential hypertension, defined as having a blood pressure of equal to or less than 130/80 in diabetics and equal to or less than 140/90 in non-diabetics. This study will investigate if the addition of 25 milligrams of eplerenone daily to a subject's hypertension medication regimen will prevent the progression or development of diastolic dysfunction. Echocardiography will be used to measure the changes in heart structure of subjects receiving eplerenone versus subjects receiving placebo (a drug that may resemble the study drug but contains no active ingredient). Approximately 30 subjects will take part in this study.
- Conditions
- Myocardial Remodeling
- Being tested
- Eplerenone, Lactose Tablet
- Keywords
- Aldosterone Blockade, Aldosterone Receptor Blockers, cardiac chamber size, wall thickness, left ventricular ejection fraction, left atrial volumes, diastolic function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Also called Inspra
25mg PO daily (QD)for 6 months
Lactose TabletDrug
Lactose tablet
| Study group | Role | What they receive |
|---|---|---|
| Lactose Tablet | Placebo comparator | Compounded capsule using Lactose Monohydrate Powder Receives: Drug: Lactose Tablet |
| Eplerenone | Active comparator | 25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder. Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram
Measured: 6 months
Secondary outcomes (1)
Blood Pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startApr 2007
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Funding ended prior to study completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial RemodelingStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Jeff Holmberg, MD, PhD, Principal investigator, Creighton Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980031
- Sponsor's protocol ID
- 07-14634
- Acronym
- Aldosterone
- Status last verified
- Mar 2014
- First submitted
- 11 Sep 2009
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension
- ClinicalTrials.gov ID
- NCT00980031
- Acronym / sponsor ID
- Aldosterone / 07-14634
- Conditions
- Myocardial Remodeling
- Keywords
- Aldosterone Blockade, Aldosterone Receptor Blockers, cardiac chamber size, wall thickness, left ventricular ejection fraction, left atrial volumes, diastolic function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended prior to study completion
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Sep 2009 (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 goal of this project is to investigate the effects that the addition of aldosterone blockade with eplerenone will have on the progression of diastolic dysfunction in patients with controlled essential hypertension.
Detailed description
The purpose of this project is to determine if eplerenone, an aldosterone blocker, prevents remodelling of the heart in patients with controlled essential hypertension, defined as having a blood pressure of equal to or less than 130/80 in diabetics and equal to or less than 140/90 in non-diabetics. This study will investigate if the addition of 25 milligrams of eplerenone daily to a subject's hypertension medication regimen will prevent the progression or development of diastolic dysfunction. Echocardiography will be used to measure the changes in heart structure of subjects receiving eplerenone versus subjects receiving placebo (a drug that may resemble the study drug but contains no active ingredient). Approximately 30 subjects will take part in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactose Tablet | Placebo comparator | Drug: Lactose TabletCompounded capsule using Lactose Monohydrate Powder |
| Eplerenone | Active comparator | Drug: Eplerenone25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Treated and controlled hypertension
- Less than 140/90 in non-diabetics
- Less than 130/80 in diabetics
Key exclusion criteria (6 listed)
- currently receiving an aldosterone blocker
- clinical evidence of congestive heart failure
- prior myocardial infarction
- renal dysfunction with a creatinine clearance of less than 40ml/min
- serum potassium > 5.5meq/L at initiation
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 |
|---|---|---|
| EplerenoneAlso: Inspra25mg PO daily (QD)for 6 months | Drug | Eplerenone |
| Lactose TabletLactose tablet | Drug | Lactose Tablet |
Primary outcome
Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram
Time frame: 6 months
1 secondary outcome
Blood Pressure
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Funding ended prior to study completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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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.
M Jeff Holmberg, MD, PhD principal investigator
Creighton Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eplerenone and Lactose Tablet in people with Myocardial Remodeling, run by Creighton University at 1 site in United States.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 28 Mar 2014. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding ended prior to study completion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram (time frame: 6 months). 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 28 Mar 2014.