CLINICAL TRIALS PROFILE FOR PRIMACOR

All Clinical Trials for PRIMACOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00543309 ↗	Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery	Terminated	American Heart Association	Phase 2	2007-10-01	The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to separate the systemic and pulmonary circulations. Although mortality following the Fontan operation is now uncommon, early postoperative morbidity including prolonged postoperative chest tube drainage and hospitalization remains significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory therapies in the perioperative period is unknown and practice varies widely between centers. The investigators will propose a single-center, randomized, double-blind, phase II clinical trial in children undergoing Fontan surgery. The investigators plan to compare the effects of perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical course and neurohumoral profile. The investigators hypothesize that, when compared to the milrinone and placebo groups, the nesiritide group will have more days alive and out of the hospital within the first 30 days after surgery.
NCT00543309 ↗	Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery	Terminated	John M Costello	Phase 2	2007-10-01	The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to separate the systemic and pulmonary circulations. Although mortality following the Fontan operation is now uncommon, early postoperative morbidity including prolonged postoperative chest tube drainage and hospitalization remains significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory therapies in the perioperative period is unknown and practice varies widely between centers. The investigators will propose a single-center, randomized, double-blind, phase II clinical trial in children undergoing Fontan surgery. The investigators plan to compare the effects of perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical course and neurohumoral profile. The investigators hypothesize that, when compared to the milrinone and placebo groups, the nesiritide group will have more days alive and out of the hospital within the first 30 days after surgery.
NCT01621971 ↗	Effect of Brief Nebulization of Milrinone on Pulmonary Arterial Pressure Before Cardiopulmonary Bypass on Mitral Valve Surgery Patients	Completed	Konkuk University Medical Center	Phase 3	2003-01-01	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.
NCT01725776 ↗	Inhaled Milrinone in Cardiac Surgery	Completed	Canadian Institutes of Health Research (CIHR)	Phase 2	2006-12-01	The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.
NCT01725776 ↗	Inhaled Milrinone in Cardiac Surgery	Completed	Fonds de la Recherche en Santé du Québec	Phase 2	2006-12-01	The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.
NCT01725776 ↗	Inhaled Milrinone in Cardiac Surgery	Completed	St. Justine's Hospital	Phase 2	2006-12-01	The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.
NCT01725776 ↗	Inhaled Milrinone in Cardiac Surgery	Completed	Montreal Heart Institute	Phase 2	2006-12-01	The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.

Clinical Trial Conditions for PRIMACOR

Condition Name

Condition Name for PRIMACOR
Intervention	Trials
Pulmonary Hypertension	3
Heart Failure	1
Pulmonary Hypoplasia	1
Heart Failure, Diastolic	1

Condition MeSH

Condition MeSH for PRIMACOR
Intervention	Trials
Hypertension, Pulmonary	6
Hypertension	5
Heart Failure	2
Hernia, Diaphragmatic	1

Clinical Trial Locations for PRIMACOR

Trials by Country

Trials by Country for PRIMACOR
Location	Trials
United States	15
Thailand	2
China	1
Canada	1
Egypt	1

Trials by US State

Trials by US State for PRIMACOR
Location	Trials
Georgia	1
California	1
Alabama	1
Tennessee	1
Kansas	1

Clinical Trial Progress for PRIMACOR

Clinical Trial Phase

Clinical Trial Phase for PRIMACOR
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for PRIMACOR
Clinical Trial Phase	Trials
Completed	5
Recruiting	4
Terminated	1

Clinical Trial Sponsors for PRIMACOR

Sponsor Name

Sponsor Name for PRIMACOR
Sponsor	Trials
Zagazig University	1
University of Kansas Medical Center	1
Mahidol University	1

Sponsor Type

Sponsor Type for PRIMACOR
Sponsor	Trials
Other	20
NIH	1