EUCTR2010-024175-58-CZActive, not recruitingPhase 1
Comparison of two treatment options for hypertension in heart transplant recipients
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- IKEM
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 <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
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
Investigators
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