A Phase 2 interventional study of Paroxetine and Placebo oral capsule in Cardiac Remodeling and Myocardial Infarction, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 2, Interventional, and Treatment
This study evaluates the off-target effect of paroxetine to reverse cardiac remodeling and improve left ventricular ejection fraction in patients after acute myocardial infarction. Half of the participants will receive paroxetine, while the other half will receive placebo treatment.
Cardiac remodeling is characterized by a composite of structural, geometric, molecular, and functional changes of the myocardium, and is an important determinant of heart failure and cardiovascular outcome in survivors of acute myocardial infarction. Progression of heart failure secondary to the remodeling process results from dysregulation of the G protein-coupled receptor (GPCR). Excessive adrenergic drive in patients with heart failure results in an enhanced activation of GPCR kinases (GRKs) that is considered to have a central role in adverse cardiac remodeling after ischemic injury. The selective Serotonin reuptake inhibitor paroxetine specifically binds to the catalytic domain of GRK2 as an off-target effect, and has been shown to reverse cardiac remodeling and increase left ventricular ejection fraction in a mouse model. The effect was observed at serum levels achieved with standard dosages of paroxetine, and was robust in mice with and without concomitant heart failure treatment, respectively.
Exclusion Criteria:
Paroxetine 20mg QD per os for 12 weeks followed by 10mg for one additional week
Drug: Paroxetine
Placebo oral capsule QD per os for 13 weeks
Drug: Placebo oral capsule
Paroxetine (Deroxat) will be administered in a dosage of 20mg q.d. per os continuously for 12 weeks after primary PCI. In week 13, Paroxetine (Deroxat) will be administered in a dosage of 10mg q.d. per os.
Also known as: Deroxat
Placebo will be given q.d. per os continuously for 12 weeks after primary PCI. In addition, a placebo will be given q.d. per os in week 13 as well.
Difference in the change of left ventricular ejection fraction (LVEF)
Assessment by cardiac magnetic resonance imaging
Time frame: 12 weeks after randomization
Difference in change in left left-ventricular end-diastolic volume (LVEDV)
Assessment by cardiac magnetic resonance imaging
Time frame: 12 weeks after randomization
Difference in change in left left-ventricular end-systolic volume (LVESV)
Assessment by cardiac magnetic resonance imaging
Time frame: 12 weeks after randomization
Difference in late-enhancement
Assessment by cardiac magnetic resonance imaging
Time frame: 12 weeks after randomization
Difference in LVEF between baseline and 12 weeks, and 12 months, respectively
Assessment by transthoracic echocardiography
Time frame: 12 months after randomization
Major adverse cardiac events
Cardiac death, myocardial infarction, repeat hospitalization for heart failure
Time frame: 12 weeks and 12 months after randomization
Clinical symptoms of heart failure
Assessed by New York Heart Association (NYHA) categorization
Time frame: 12 weeks and 12 months after randomization
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern