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
Similar Trials
Completed
Not Applicable
Comparison of the effect of anti-hypertensive treatment with verapamil and amlodipine on the coronary vasodilator reserve and the transmural distribution of myocardial blood flow in hypertensive patients with left ventricular hypertrophyCirculatory SystemHypertensionISRCTN35563487Abbott (Germany)50
Completed
Phase 4
Comparing anti-hypertensive combination therapy of fixed dose losartan and hydrochlorothiazide(HCTZ) versus angiotensin receptor blocker(ARB) and calcium channel blocker(CCB) on hypertensive patients whose blood pressures don't lower enough,effect and influence of metabolic system trial.HypertensionJPRN-UMIN000001692Hypertension and Metabolism Study group in East Saitama300
Active, not recruiting
Not Applicable
Application of physiotherapy to reduce pressurehypertensionRBR-5jt8k2Faculdade Independente do Nordeste - FAINOR
Completed
Not Applicable
Comparison of antihypertensive medical care using telemedicine vs. conventional therapyEssential HypertensionJPRN-UMIN000025372Tokyo Women's Medical University450
Unknown
Not Applicable
Community-based Microalbuminuria Screening in Patients With HypertensionMicroalbuminuriaHypertensionNCT03596840Shanghai Zhongshan Hospital3,000
