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MR Antagonist
MR Antagonist for High Blood Pressure
Phase 4
Recruiting
Led By Andrea Haas, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Untreated as well as currently treated hypertensives
Normal renal, metabolic, electrolyte, and CBC laboratory tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in systolic blood pressure between baseline and 4 weeks on study drug
Awards & highlights
Study Summary
This trial is investigating whether a genetically-driven anti-hypertensive approach is better at controlling blood pressure and mitigating renal damage in Blacks who carry the risk allele for LSD1.
Who is the study for?
This trial is for Black individuals over 17 years old with high blood pressure, who may be on up to two blood pressure medications and have normal kidney function and lab tests. They must carry the rs587168 risk allele for LSD1. People with heart disease other than hypertension, diabetes, or a history of smoking are not eligible.Check my eligibility
What is being tested?
The study is testing whether using Eplerenone (an MR antagonist) can better control blood pressure and prevent kidney damage in Blacks carrying the rs587168 allele compared to Amlodipine, based on their genetic makeup.See study design
What are the potential side effects?
Eplerenone may cause increased potassium levels, dizziness or diarrhea; Amlodipine might lead to swelling, fatigue or palpitations. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high blood pressure, treated or untreated.
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My kidney function and blood tests are normal.
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I am older than 17 years.
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I carry the Rs587168 allele.
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I am taking two or fewer medications for high blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in systolic blood pressure between baseline and 4 weeks on study drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in systolic blood pressure between baseline and 4 weeks on study drug
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24-hour systolic ambulatory blood pressure
Side effects data
From 2012 Phase 4 trial • 1012 Patients • NCT011769685%
Chest pain
4%
Diarrhoea
4%
Hypotension
4%
Dizziness
3%
Abdominal pain upper
3%
Angina pectoris
3%
Cough
3%
Non-cardiac chest pain
2%
Anxiety
2%
Bradycardia
2%
Ventricular tachycardia
2%
Hypertension
2%
Dyspnoea
2%
Fatigue
2%
Oedema peripheral
2%
Diabetes mellitus
2%
Back pain
2%
Headache
1%
Constipation
1%
Nausea
1%
Pericarditis
1%
Cardiac failure
1%
Angina unstable
1%
Myocardial infarction
1%
Cerebrovascular accident
1%
Syncope
1%
Acute myocardial infarction
1%
Peripheral arterial occlusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eplerenone Plus Standard of Care
Placebo Plus Standard of Care
Trial Design
2Treatment groups
Experimental Treatment
Group I: Eplerenone ArmExperimental Treatment1 Intervention
We posit that individuals who carry the LSD1 risk allele have increased mineralocorticoid receptor activity, which results in hypertension. Thus, our mechanistic clinical study will assess whether hypertensive LSD1 risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the LSD1 risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
Group II: Amlodipine ArmExperimental Treatment1 Intervention
We posit that individuals who carry the LSD1 risk allele have increased mineralocorticoid receptor activity, which results in hypertension. Thus, our mechanistic clinical study will assess whether hypertensive LSD1 risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the LSD1 risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amlodipine
2004
Completed Phase 4
~40680
Eplerenone
2015
Completed Phase 4
~6640
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,530 Total Patients Enrolled
Andrea Haas, MDPrincipal InvestigatorBrigham and Women's
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes.You are a smoker.I have high blood pressure due to another health condition.I have high blood pressure, treated or untreated.My kidney function and blood tests are normal.You identify yourself as being Black.I have kidney, blood circulation, or nerve problems.I am older than 17 years.I carry the Rs587168 allele.I have a heart condition that is not high blood pressure.I am taking two or fewer medications for high blood pressure.I am not on any medication except for blood pressure or stable thyroid replacement.
Research Study Groups:
This trial has the following groups:- Group 1: Amlodipine Arm
- Group 2: Eplerenone Arm
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is Eplerenone commonly utilized in medical treatments?
"Eplerenone is a drug typically used to combat cardiovascular events. This medication can also be effective at managing high cardiac risk, dyslipidemias, and coronary artery disease (CAD)."
Answered by AI
Is enrollment currently open for this research experiment?
"Affirmative. Clinicaltrials.gov's data affirms that this research project, which was initially published on February 3rd 2022, is presently enrolling volunteers. The investigation requires 300 participants to be enrolled from a single medical centre."
Answered by AI
Are there additional studies that have been conducted on the effects of Eplerenone?
"Forty separate investigations into the efficacy of Eplerenone are currently underway with 8 trials in Phase 3. The greatest concentration of research is located in Nagoya, Aichi; however, there are 336 locations globally hosting studies for this drug."
Answered by AI
How many patients have been enrolled in the trial thus far?
"Affirmative. According to clinicaltrials.gov, this ongoing medical trial was initially posted on February 3rd 2022 and has since been modified most recently on July 20th 2022. The study requires 300 participants from one single site."
Answered by AI
Are there any potential risks associated with the usage of Eplerenone?
"Based on Phase 4 trial data, the safety of Eplerenone is rated at 3 out of 3 by our team. This drug has already been approved for use in patients."
Answered by AI
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