Comparison of two treatment regimen of high blood pressure in patients with transplanted heart.
- Conditions
- Compensation of arterial hypertension in heart transplant recipients. Renal function and its changes in heart transplant recipients.MedDRA version: 13.1Level: HLTClassification code 10038454Term: Renal function analysesSystem Organ Class: 10022891 - InvestigationsMedDRA version: 13.1Level: LLTClassification code 10020775Term: Hypertension arterialSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-024175-58-CZ
- Lead Sponsor
- IKEM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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 <5 mmol / l
5) Serum creatinine lower or equal than 150 micromol / l glomerular filtration rate > 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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