Compensation of arterial hypertension in heart transplant recipients. Renal function and its changes in heart transplant recipients. MedDRA version: 13.1 Level: HLT Classification code 10038454 Term: Renal function analyses System Organ Class: 10022891 - Investigations MedDRA version: 13.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: PRESTARIUM Neo
Product Name: perindopril
Pharmaceutical Form: Coated tablet
CAS Number: 82834-16-0
Other descriptive name: PERINDOPRIL ARGININE
Concentration unit: mg milligram(s)
Concentr
Sponsors
IKEM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged between 18-65 years ,who are undergoing heart transplantation, and who develop hypertension during the first 6 months, which will require treatment 2) A patient who understands the purpose of the study, which was fully informed and gave written consent to participate in the study 3) blood pressure> 130/80 mmHg 4) The value of serum potassium 1.0 ml / s 6) No serious complications associated with surgery (graft failure ,hemodynamic instability, severe acute rejection, renal failure) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patient after heart transplantation more than 6 months 2) The presence of serious complications after heart transplantation (graft failure, hemodynamic instability, severe acute rejection) 3) Hyperkalemia (serum potassium concentration> 5.3 mmol / l) 4) Current use of potassium-sparing diuretics 5) Patients with significant renal impairment defined as an increase creatinine higher or equal to 250 umol/l 6) Patients with significantly elevated liver function tests (defined as AST and ALT increased to three times the normal values 7) Anemia (hemoglobin <90 g / l) 8) Retransplantation or multiorgan transplantation 9) Women who are unable or unwilling to use two barrier contraception 10) Pregnant women or nursing mothers 11) Inability to take oral medication 12) Patients unable to give informed consent 13) Patients with mental disorder or condition, which in the opinion investigator might compromise communication with the investigator 14). Participation of patients in another clinical trial during the last 30 days 15). Patients with known sensitivity (sensitivity) of perindopril or losartan or a chemically related components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of efficacy of treatment of hypertension in heart transplant recipients which is the combination of an ACE inhibitor and angiotensin II receptor antagonist (group A) with standard antihypertensive therapy used in our department (group B). The measure of effectiveness is the achievement of blood pressure compensation.;Secondary Objective: Effect of dual blockade of the renin-angiotension system on renal function measuring by the glomerular filtration rate, proteinuria, microalbuminuria, and specific proteins (transferrin and alfa-1 microglobulin).;Primary end point(s): Compensentation of blood pressure.;Timepoint(s) of evaluation of this end point: 10 day, 30.day, 3., 6., 9. and 12 month after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Renal function measured by the glomerular filtration rate, proteinuria, microalbuminuria, and specific proteins (transferrin and alfa-1 microglobulin);Timepoint(s) of evaluation of this end point: 10 day, 30.day, 3., 6., 9. and 12 month after randomization | — |
Countries
Czech Republic
Contacts
Public ContactLenka Hoskova
IKEM
Outcome results
None listed