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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

Must not have

Diabetes

Secondary HTN as indicated by history, physical examination or screening blood and urine tests

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in systolic blood pressure between baseline and 4 weeks on study drug

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I have high blood pressure due to another health condition.

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I have a heart condition that is not high blood pressure.

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I am not on any medication except for blood pressure or stable thyroid replacement.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in systolic blood pressure between baseline and 4 weeks on study drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24-hour systolic ambulatory blood pressure

Side effects data

From 2012 Phase 4 trial • 1012 Patients • NCT01176968

Chest pain

Diarrhoea

Hypotension

Dizziness

Angina pectoris

Abdominal pain upper

Cough

Non-cardiac chest pain

Dyspnoea

Hypertension

Bradycardia

Anxiety

Ventricular tachycardia

Fatigue

Oedema peripheral

Diabetes mellitus

Back pain

Headache

Pericarditis

Nausea

Constipation

Cardiac failure

Angina unstable

Myocardial infarction

Cerebrovascular accident

Syncope

Acute myocardial infarction

Peripheral arterial occlusive disease

100%

80%

60%

40%

20%

Study treatment Arm

Eplerenone Plus Standard of Care

Placebo Plus Standard of Care

Awards & Highlights

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.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amlodipine

2004

Completed Phase 4

~40680

Eplerenone

2015

Completed Phase 4