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
Organization
Brigham and Women's HospitalProduct
EplerenoneIndication
HypertensionIndication
Mineralocorticoid ExcessDrug
Amlodipine