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Phosphodiesterase Inhibitor

Inhaled nebulized milrinone for Heart Failure (iMilrinone Trial)

Phase 1
Waitlist Available
Led By Nicholas Haglund, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up plasma samples will be drawn around the 4th inhaled dose and after the dose at the following time point of 8 hours to assess for serum milirinone concentration fro the trough to be no less than 50ng/ml and the peak to be no greater than 500ng/ml.
Awards & highlights

iMilrinone Trial Summary

This trial is testing a new way to give the heart failure medication milrinone using an inhaler instead of through an IV. The goal is to see if this new way lowers the levels of plasma milrinone, which may lessen the chance of medication side effects, while still preserving the beneficial effects of milrinone.

Eligible Conditions
  • Heart Failure
  • Cardiomyopathy

iMilrinone Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~plasma samples will be drawn around the 4th inhaled dose and after the dose at the following time point of 8 hours to assess for serum milirinone concentration fro the trough to be no less than 50ng/ml and the peak to be no greater than 500ng/ml.
This trial's timeline: 3 weeks for screening, Varies for treatment, and plasma samples will be drawn around the 4th inhaled dose and after the dose at the following time point of 8 hours to assess for serum milirinone concentration fro the trough to be no less than 50ng/ml and the peak to be no greater than 500ng/ml. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic analysis
Safety Analysis
Secondary outcome measures
All cause mortality
Other outcome measures
Study Withdrawal Criteria -1
Withdrawal criteria - 2
Withdrawal criteria - 3
+4 more

Side effects data

From 2017 Phase 2 trial • 72 Patients • NCT02232399
9%
Junctional ectopic tachycardia
9%
Inotropic score > 20
6%
Third-degree atrioventricular block
3%
Upper respiratory tract infection
3%
AV block III
3%
Blood culture verified S. aureus sepsis
3%
Readmission
3%
Re-operation and dialysis post re-operation
3%
Enalapril caused prolonged hospitalisation
3%
Fever and diarrea
3%
Postoperative AV-block
3%
hydrocephalus and seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levosimendan
Milrinone

iMilrinone Trial Design

1Treatment groups
Experimental Treatment
Group I: Inhaled nebulized milrinoneExperimental Treatment1 Intervention
Inhaled nebulized milrinone 60mg/4ml every 8 hours using a jet nebulizer

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
462 Previous Clinical Trials
169,197 Total Patients Enrolled
4 Trials studying Heart Failure
379 Patients Enrolled for Heart Failure
Vanderbilt University Medical CenterOTHER
857 Previous Clinical Trials
672,187 Total Patients Enrolled
12 Trials studying Heart Failure
5,003 Patients Enrolled for Heart Failure
Nicholas Haglund, MDPrincipal Investigator - University of Kansas
University of Kansas Hospital
St George'S University (Medical School)
Maine Medical Center (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nebulized Inhaled Milrinone in a Hospitalized Advanced Heart Failure Population
Nicholas Haglund 2020. "Nebulized Inhaled Milrinone in a Hospitalized Advanced Heart Failure Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02077010.
All > Heart Failure With Preserved Ejection Fraction
~2 spots leftby Apr 2025
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