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OpenTrials
Active, Not Recruiting

NCT Number: NCT04840342

MR Antagonist and LSD1

Lysine specific demethylase-1 (LSD1) is an epigenetic regulator of gene transcription involved in the pathophysiology of elevated blood pressure and likely renal damage in Blacks. This project investigates whether a genetically driven anti-hypertensive approach proves superior in controlling blood pressure and mitigating renal injury in Blacks who carry the risk allele for LSD1 (rs587168). The findings of these investigations may lead to a new approach in treating a subset (~30%) of the essential hypertension population (Black LSD1 risk allele hypertensives).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Mineralocorticoid Excess Vascular Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's

Boston, Massachusetts, 02115, United States

About this study

This proof-of-principle physiologic study in hypertensive Black LSD1 risk allele carriers testing the hypothesis that reductions in blood pressure will be greater with a genetically-driven anti-hypertensive approach (mineralocorticoid receptor antagonist, eplerenone) compared to a non-specific approach (amlodipine). 56 participants will be enrolled in a 12-week randomized, double-blind, active controlled, outpatient study to assess whether eplerenone (LSD1 specific treatment) proves superior in 24-hr ambulatory systolic blood pressure reduction than amlodipine (non-specific treatment). Participants will be randomized to either eplerenone 50mg or amlodipine 2.5mg with escalations in dose of study drug every 4 weeks if the participant's blood pressure is > 140/90.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • untreated as well as currently treated hypertensives
  • rs587168 allele carriers
  • not on more than two anti-hypertensives
  • normal renal, metabolic, electrolyte, and CBC laboratory tests
  • self-identified Black race
  • age >17 yrs.

Exclusion criteria

  • known cardiac disease other than HTN
  • renal, circulatory or neurologic diseases
  • diabetes
  • smoking
  • secondary HTN as indicated by history, physical examination or screening blood and urine tests
  • smoking
  • any drug therapy, except for anti-hypertensives and stable thyroid medication replacement

Treatment and study plan

Eplerenone

Drug

Dose escalations of eplerenone 50, 100, or 200mg

Amlodipine

Drug

Dose escalations of amlodipine 2.5, 5, or 10mg

Primary outcomes

  1. 24-hour systolic ambulatory blood pressure

    Time frame: Change in systolic blood pressure between baseline and 4 weeks on study drug

    Subjects will be counseled regarding liberal salt dietary intake to ensure similar intakes in all subjects [Na+ (200 mEq), potassium (K+, 100 mEq) and calcium (800 mg)]. After completion of this diet for 6 days, the subject will collect a 24-hour ambulatory blood pressure. Procedure will be performed before randomization and after 4 weeks of therapy.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Role of LSD1 in Hypertension in Blacks

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 12, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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