MedTrace Logo

Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3

NCT04649229 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-17

No results posted yet for this study

Summary

This is a double-blind, randomized, two x two crossover (aprepitant vs placebo) during both initiation of Entresto, LCZ696, (50 mg dose) and at steady-state of Entresto (200 mg bid dose or the highest tolerated dose).

Conditions

Interventions

DRUG

LCZ 696

Treatment with LCZ696 is unblinded in this study. After the two acute study days, subjects will be provided LCZ696 50 mg bid for two weeks. At the end of those two weeks subjects will report to the Clinical Research Center (CRC) for a dose escalation visit. If their tolerance, blood pressure, potassium, and eGFR meet escalation criteria they will be given LCZ696 100 mg bid for three weeks. (If they do not meet escalation criteria they will be continued on LCZ696 50 mg bid.) After three weeks, they will return to the CRC for the next escalation visit. If they meet criteria for escalation they will be given LCZ 200 mg bid for ten days. (If they do not meet escalation criteria they will be continued on the highest tolerated dose).

DRUG

Placebo

Placebo or aprepitant 120 mg will be given orally on study days 1 and 2 and again on study days 3 and 4

DRUG

Para-aminohippurate

Para-aminohippurate (PAH) will be given at a dose of 8 mg/kg loading dose followed by a 12 mg/min steady-state infusion during each study day.

DRUG

Iohexol

Iohexol will be given as 5 mL of iohexol solution (3.235 g iohexol) intravenously on each study day.

DRUG

Aprepitant

Placebo or aprepitant 120 mg will be given orally on study days 1 and 2 and again on study days 3 and 4

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Nancy J. Brown, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2025-05-22
Completion
2025-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04649229 on ClinicalTrials.gov