Mechanism(s) Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 1

NCT03738878 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-08-03

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Summary

The purpose of this study is to test the hypothesis that combined angiotensin receptor blockade (ARB)/neprilysin (NEP) inhibition potentiates the effects of exogenous bradykinin, substance P, and brain natriuretic peptide (BNP) on forearm blood flow or endothelial tissue-type plasminogen activator (t-PA) release compared to ARB alone. A secondary goal is to determine if there is an interactive effect of ARB/NEP inhibition and dipeptidyl peptidase 4 (DPP4) inhibition on responses to these peptides.

Conditions

Interventions

DRUG

Valsartan

oral valsartan

DRUG

LCZ696

oral LCZ696

DRUG

Bradykinin

Intra-arterial bradykinin at three graded doses

DRUG

Substance P

Intra-arterial substance P at three graded doses

DRUG

BNP

Intra-arterial BNP at three graded doses

DRUG

Sitagliptin

oral sitagliptin

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2024-12-01
Completion
2024-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03738878 on ClinicalTrials.gov