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NCT04113109 · ClinicalTrials.gov registry record · Phase 4
Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT04113109: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.
NCT04113109 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 46 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04113109, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study Summary
LCZ696, a molecular complex of the angiotensin receptor blocker (ARB) valsartan with an inhibitor of neprilysin (NEP, neutral endopeptidase-24.11) sacubitril improved mortality compared to enalapril in patients with heart failure (HF), reduced ejection fraction (EF), and increased brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) in the PARADIGM-HF trial.1 The PIONEER-HF study demonstrated the efficacy of LCZ696 in preventing rehospitalization in patients with acutely decompensated HF.2 LCZ696 has been underutilized in heart failure, in part due to concerns about hypotension. NEP degrades several vasodilator peptides including bradykinin, substance P and brain-type natriuretic peptide. Decreased degradation of endogenous bradykinin could contribute to hypotension at initiation of LCZ696 through vasodilation or through increased natriuresis and diuresis. Inhibition of the bradykinin B2 receptor using icatibant would be expected to prevent this effect. Objectives The main objectives of this mechanistic randomized, double-blind, crossover-design study are: * The primary objective is to test the hypothesis that endogenous bradykinin contributes to effects of ARB/NEP inhibition on blood pressure, natriuresis, and diuresis at initiation. * The secondary objective is to test the hypothesis endogenous bradykinin contributes to effects of ARB/NEP inhibition on blood pressure, natriuresis, and diuresis after up-titration. Eighty (80) subjects with stable heart failure who meet all inclusion/exclusion criteria will be enrolled. Subjects who qualify will collect their urine for 24 hours before each study day for measurement of volume, sodium and potassium. At the start of the study, they will stop their regular angiotensin-converting enzyme (ACE) inhibitor or ARB. After a 48-hour washout, they will undergo a study day in which they are given a single dose of 50 mg LCZ696. They will also receive either the bradykinin B2 receptor antagonist icatibant or place
Primary Outcome
Mean arterial pressure (MAP) will be measured before and after administration of LCZ696 on each of the four study days.
Interventions
- DRUG placebo
- DRUG Iohexol
- DRUG Icatibant
- DRUG LCZ 696
- DRUG Para-aminohippurate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2025-07-30 |
| Phase | Phase 4 |
What the finished NCT04113109 record still lists
NCT04113109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT04113109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04113109 about?
NCT04113109 is a clinical study titled "Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2". LCZ696, a molecular complex of the angiotensin receptor blocker (ARB) valsartan with an inhibitor of neprilysin (NEP, neutral endopeptidase-24.11) sacubitril improved mortality compared to enalapril in patients with heart failure (HF), reduced ejection fraction (EF), and increased brain natriuretic ...
What is the current status of trial NCT04113109?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2019-11-01. Estimated completion is 2025-07-30.
What interventions are being tested in trial NCT04113109?
The interventions under investigation include: placebo (DRUG), Iohexol (DRUG), Icatibant (DRUG), LCZ 696 (DRUG), Para-aminohippurate (DRUG).
Who is sponsoring clinical trial NCT04113109?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04113109's enrollment target sits among peer trials
46 1348th of 2000 higher than 647 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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