Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Right Ventricular Dysfunction and End Stage Heart Disease, sponsored by University of Nebraska.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
1. Arrhythmias: * Atrial * Ventricular 2. 'Sustained' hypotension 3. Hypersensitivity reaction to milrinone
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 |
What the finished NCT01571037 record still lists
NCT01571037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 241-participant average among 5 other Right Ventricular Dysfunction trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Right Ventricular Dysfunction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Repurposing Valsartan May Protect Against Pulmonary Hypertension
RECRUITING · Phase 2
-
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
RECRUITING
-
Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise
RECRUITING · NA
-
Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE
ACTIVE NOT RECRUITING · Phase 4
-
A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI