PeriPartum Cardiomiopathy
Conditions
Interventions
Trade Name: Bromocorn 2,5 mg
Product Name: Bromocorn 2,5 mg
Pharmaceutical Form: Tablet
Sponsors
The Cardinal Stefan Wyszynski Institute of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study group: - age = 18 years of age - newly diagnosed heart failure, which occurred in the period from 24 weeks of pregnancy to 6 months after delivery - LVEF =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Study group: - age 6 months after delivery, - normal left ventricular ejection fraction in echocardiography, - the presence of other causes of heart failure, heart disease found before pregnancy - diagnosed cardiomyopathy> 1 month prior to study enrollment, - contraindications to treatment with bromocriptine, which include i.a. uncontrolled hypertension, allergy to any component of the drug, symptoms of mental disorders or a history of severe mental disorders. - participation in another clinical trial with drug administration or use of a device prior to randomization - lack of informed consent to participate in the study. Control group: - age <18 years old, - heart disease diagnosed before or during pregnancy, - lack of informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The project aims to assess the therapeutic effect of the new, intensified treatment regimen with bromocriptine at a dose of 2 x 2.5 mg for 14 days, then 1 x 2.5 mg for min. 42 days with an additional extension of therapy in NYHA class> I patients, no improvement in LVEF in TTE (LVEF <35% or no increase in LVEF by 10%) compared to the 7-day administration of bromocriptine at the minimum dose of 1 x 2.5 mg necessary to inhibit lactation.;Secondary Objective: 1. Creation of a new diagnostic scheme in PPCM, taking into account new biomarkers and biomarkers with already proven relationship with PPCM selected in the Project 2. Development of a new reference key determination method in PPCM, 3. A summary of the data on the severity of the fibrosis process, resulting from the concentration of the determined biomarkers, with the initial and six-month observation of the magnetic resonance image (including extended T1 and T2 times, ECV, LGE, GLS), as well as compared with selected echocardiographic parameters, 4. Discovery of new mutations in genes for which the relationship with PPCM has not been shown so far.;Primary end point(s): The health effect endpoints against which the clinical effectiveness of prolonged bromocriptine treatment will be assessed compared to the 7-day treatment group include: - improvement in left ventricular ejection fraction (LVEF) =50%, increase in LVEF by 10 units (%) and delta of mean LVEF increase as assessed by transthoracic echocardiography and cardiac magnetic resonance imaging (CMRI) over a 6-month follow-up; - composite endpoint including hospitalizations for cardiovascular causes, mechanical support of the left ventricle, heart transplantation, sudden cardiac arrest including ventricular arrhythmias interrupted by the discharge of an implanted cardioverter-defibrillator, death from cardiovascular causes.;Timepoint(s) of evaluation of this end point: Timing of the Primary Endpoint evaluation: final visit, end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - days alive out of hospitalization; - the appearance of ventricular arrhythmia or atrial fibrillation; - improvement of cardiovascular capacity by at least one NYHA class; - improvement in the quality of life assessed using the abbreviated version of the World Health Organization (WHO) quality of life survey WHOQOL-BREF;Timepoint(s) of evaluation of this end point: - isolation of a biomarker or a set of biomarkers (from among the 16 kDa PRL, sFlt1, PlGF, PAI-1, 30 miR panel, including miR146a, Gal-3, PINP, PIIINP, MPO, MMP-1, TIMP-1), which will be the optimal indicator of the presence of PPCM - based on the concentration of biomarkers in the group of patients with PPCM at the time of diagnosis compared with their concentrations in the control group in a given time interval of pregnancy / puerperium (Table 1.2); - separation of a biomarker which is the optimal indicator of response to bromocriptine therapy or persistence of severe heart failure in patients with PPCM over a 6-month follow-up; - discovery of new mutations related to the occurrence of PPCM | — |
Countries
Poland
Contacts
Public ContactClinical Trial Information Desk
Aneta Wielgosz
Outcome results
None listed