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Thiazide diuretics versus calcium channel blockers for the treatment of calcineurin inhibitor-induced hypertension in patients with psoriasis or eczema: a single-center randomized cross-over trial.

Withdrawn
Conditions
Hypertension or high blood pressure
10057166
Registration Number
NL-OMON40718
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
22
Inclusion Criteria

* Treatment with cyclosporine
* 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
* Pre-existent hypertension
* Elevated uric acid levels during the use of thiazide diuretics

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Change in average 24-hour systolic blood pressure after eight weeks of<br /><br>treatment.</p><br>
Secondary Outcome Measures
NameTimeMethod
<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 cyclosporine level<br /><br>- Occurrence of gout</p><br>
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