NCT04840342

MR Antagonist and LSD1

Role of LSD1 in Hypertension in Blacks

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Hypertension
• Mineralocorticoid Excess

Interventions

Type	Name	Description
DRUG	Eplerenone	Dose escalations of eplerenone 50, 100, or 200mg
DRUG	Amlodipine	Dose escalations of amlodipine 2.5, 5, or 10mg

Timeline

• Start date: 2022-02-03
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2021-04-12
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States