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NCT04191681 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
A Phase 4 study of Stage D Heart Failure, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04191681: Recruiting Phase 4 study of Stage D Heart Failure, sponsored by The Cleveland Clinic.
NCT04191681 is a Phase 4 study of Stage D Heart Failure that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04191681, a Phase 4 study of Stage D Heart Failure, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device (CF-LVAD) implantation compared to usual care oral vasodilator therapy.
Primary Outcome
Incidence of drug discontinuation from drug-related adverse events due to sacubitril-valsartan versus standard-of-care oral vasodilator therapy evaluated at 3 months. Incidence of drug discontinuation is defined as the number of patients exposed to the drug with an adverse event over the total number of patients exposed to the drug. An adverse event is defined as any one of the following: acute kidney injury with eGFR decline \> 25% from baseline, hyperkalemia with potassium \> 5.5 mM, hypotensi
Conditions Studied
Interventions
- DRUG Sacubitril-Valsartan
- DRUG Usual care (standard-of-care) arm
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-11-08 |
| Est. Completion | 2022-12 |
| Phase | Phase 4 |
What NCT04191681 shows while recruiting
NCT04191681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Stage D Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Sacubitril-Valsartan is the first listed.
NCT04191681 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04191681 about?
NCT04191681 is a clinical study titled "Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study". The purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device (CF-LVAD) implantation compared to usual care oral vasodilator therapy.
What is the current status of trial NCT04191681?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2019-11-08. Estimated completion is 2022-12.
What conditions does trial NCT04191681 study?
This clinical trial studies the following conditions: Stage D Heart Failure.
What interventions are being tested in trial NCT04191681?
The interventions under investigation include: Sacubitril-Valsartan (DRUG), Usual care (standard-of-care) arm (DRUG).
Who is sponsoring clinical trial NCT04191681?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04191681 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04191681's enrollment target sits among peer trials
50 1255th of 2000 higher than 679 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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