Thiazide diuretics versus calcium channel blockers for the treatment of tacrolimus-induced hypertension in dermatology patients: a single-center randomized cross-over trial.

Recruiting

Conditions: Hypertension or high blood pressure
10057166

Registration Number: NL-OMON39664

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 73

Inclusion Criteria

• Treatment with tacrolimus
• MDRD-GFR >= 30 ml/min
• Systolic blood pressure > 140 mmHg but < 180 mmHg during 24-hours blood pressure measurement
• Stable background antihypertensive drugs (i.e., no anticipated change in dose during the study period)
• 18 years or older

Exclusion Criteria

• MDRD-GFR < 30 ml/min
• Serum sodium < 136 mmol/l
• Serum potassium < 3.5 mmol/l
• Proteinuria > 1.0 g/10 mmol creatinine
• Systolic blood pressure < 140 mmHg during 24-hour blood pressure measurement
• The use of co-trimoxazol or prednisone
• Incapacitated subjects
• Pregnancy
• Simultaneous use of thiazides and calcium channel blockers.
• Use of loopdiuretics

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Average 24-hour systolic blood pressure after eight weeks of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Incidence of hyperkalemia (serum potassium > 5.0 mmol/l)<br /><br>• Incidence of non-anion gap metabolic acidosis (serum bicarbonate < 20 mmol/l)<br /><br>• Incidence of edema (as assessed by physical examination)<br /><br>• Number of antihypertensive drugs<br /><br>• Side-effects:<br /><br>- Decrease in MDRD-GFR<br /><br>- Development of hyponatremia<br /><br>- Development of hypomagnesemia<br /><br>- Development of hypokalemia<br /><br>- Increase in HbA1c<br /><br>- Fluctuation in plasma tacrolimus level<br /><br>- Occurrence of gout </p><br>