NCT01621971

Brief Summary

Our main hypothesis is that inhalation of milrinone can reduce the elevated pulmonary arterial pressure due to severe mitral valve regurgitation without compromising systemic hemodynamics. Therefore, the effects of a brief inhaled milrinone (IH) on pulmonary artery pressure are determined and compared to those of intravenous milrinone (IV) in severe mitral regurgitation patients undergoing mitral valve surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 14, 2012

Last Update Submit

June 18, 2012

Conditions

Pulmonary HypertensionMitral Regurgitation

Keywords

inhaled milrinonepulmonary hypertensionmitral regurgitationmitral valve surgery

Outcome Measures

Primary Outcomes (1)

  • transpulmonary pressure gradient

    transpulmonary pressure gradient (TPG= mean PAP-PAOP) before and 10 min after completely administering the study drug

    10 min after milrinone administration

Secondary Outcomes (4)

  • mean pulmonary arterial pressure

    10 min after milrinone administration

  • mean arterial pressure

    10 min after milrinone administration

  • systemic vascular resistance

    10 min after milrinone administration

  • pulmonary vascular resistance

    10 min after milrinone administration

Study Arms (2)

milrinone inhalation

EXPERIMENTAL

inhaled milirinone and IV placebo (0.9% normal saline 0.05 ml/kg) are administered in Group IH.

Drug: inhaled milrinone

intravenous milrinone

ACTIVE COMPARATOR

After performing the sternotomy and achieving stable hemodynamics, but before the initiation of CPB, inhaled placebo (distilled water) and an IV bolus of milrinone (50 μg/kg) are administered in Group IV

Drug: intravenous milrinone

Interventions

inhaled milrinoneDRUG

After performing the sternotomy and achieving stable hemodynamics, but before the initiation of CPB, inhaled milirinone and intravenous placebo (0.9% normal saline 0.05 ml/kg) are administered

Also known as: Primacor, Sanofi-Synthelabo Canada Inc., Markham, ON, Canada
milrinone inhalation
intravenous milrinoneDRUG

After performing the sternotomy and achieving stable hemodynamics, but before the initiation of CPB, inhaled placebo (distilled water) and an intravenous bolus of milrinone (50 μg/kg) are administered

Also known as: Primacor, Sanofi-Synthelabo Canada Inc., Markham, ON, Canada
intravenous milrinone

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing mitral valve surgery for chronic mitral regurgitation
  • estimated pulmonary hypertension (systolic PAP \> 50 mmHg estimated by the velocity of tricuspid valve regurgitation in preoperative transthoracic echocardiography)
  • patients who agreed to participate in this study and signed written informed consent

You may not qualify if:

  • preoperative supraventricular tachycardia (SVT),
  • atrial fibrillation,
  • atrial flutter,
  • multiple ventricular ectopic contractions,
  • continuous inotropic support,
  • LV ejection fraction (EF) \< 30%,
  • emergent surgery,
  • obstructive cardiomyopathy,
  • bronchial asthma
  • biochemical evidence of hepatic disease or renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 143729, South Korea

Location

MeSH Terms

Conditions

Hypertension, PulmonaryMitral Valve Insufficiency

Interventions

Milrinone

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart Valve DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

AmrinoneAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tae-Yop Kim, MD PhD

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 18, 2012

Study Start

January 1, 2003

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

KR(1)