Clinical trial

Role of LSD1 in Hypertension in Blacks

Name
2021p000990
Description
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).
Trial arms
Trial start
2022-02-03
Estimated PCD
2026-02-01
Trial end
2026-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Eplerenone
Dose escalations of eplerenone 50, 100, or 200mg
Arms:
Eplerenone Arm
Amlodipine
Dose escalations of amlodipine 2.5, 5, or 10mg
Arms:
Amlodipine Arm
Size
300
Primary endpoint
24-hour systolic ambulatory blood pressure
Change in systolic blood pressure between baseline and 4 weeks on study drug
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-08-01

1 organization

1 product

1 drug

2 indications

Product
Eplerenone
Indication
Hypertension