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NCT01571037 · ClinicalTrials.gov registry record · Phase 1
Inhaled Milrinone Use in Patients Receiving HeartMate II LVAD: A Pilot Study
A Phase 1 study of Right Ventricular Dysfunction and End Stage Heart Disease, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01571037 is a Phase 1 study of Right Ventricular Dysfunction and End Stage Heart Disease that has completed, run by University of Nebraska. The registered enrollment target is 10 participants, below the 241-participant average among 5 other Right Ventricular Dysfunction trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01571037, a Phase 1 study of Right Ventricular Dysfunction and End Stage Heart Disease, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left ventricular assist device (LVAD) implantation and has been shown to adversely affect peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and post-operatively are limited. Inhaled milrinone has been shown in several small human studies to be safely tolerated and provide favorable effects on pulmonary hemodynamics. Study Hypothesis: Delivery of inhaled milrinone, a phosphodiesterase III inhibitor, may provide pulmonary artery vasodilation and therefore improved RV function in patients with end stage heart failure receiving HeartMate II LVAD as a bridge to cardiac transplantation or as destination therapy. Specifically, we aim to: * demonstrate safety of inhaled milrinone in this patient cohort * demonstrate efficacy of inhaled milrinone in this patient cohort
Conditions Studied
Interventions
- DRUG Inhaled, nebulized, Milrinone
- DRUG inhaled nebulized milrinone
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-04-05 |
| Est. Completion | 2014-02-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01571037
The ClinicalTrials.gov registry entry for NCT01571037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 241-participant average among 5 other Right Ventricular Dysfunction trials with a reported enrollment target (96% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Right Ventricular Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Inhaled, nebulized, Milrinone is the first listed.
NCT01571037 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT01571037 about?
NCT01571037 is a clinical study titled "Inhaled Milrinone Use in Patients Receiving HeartMate II LVAD: A Pilot Study". Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left ventricular assist device (LVAD) implantation and has been shown to adversely affect peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and post-operatively are limited. Inhaled m...
What is the current status of trial NCT01571037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2012-04-05. Estimated completion is 2014-02-21.
What conditions does trial NCT01571037 study?
This clinical trial studies the following conditions: Right Ventricular Dysfunction, End Stage Heart Disease.
What interventions are being tested in trial NCT01571037?
The interventions under investigation include: Inhaled, nebulized, Milrinone (DRUG), inhaled nebulized milrinone (DRUG).
Who is sponsoring clinical trial NCT01571037?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01571037 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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