To compare the blood pressure lowering effect of thiazides against calcium channel blockers in CNI-induced hypertension.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Average 24-hour systolic blood pressure after eight weeks of treatment.
Secondary outcome
• Incidence of hyperkalemia (serum potassium > 5.0 mmol/l)
• Incidence of non-anion gap metabolic acidosis (serum bicarbonate < 20 mmol/l)
• Incidence of edema (as assessed by physical examination)
• Number of antihypertensive drugs
• Side-effects:
- Decrease in MDRD-GFR
- Development of hyponatremia
- Development of hypomagnesemia
- Development of hypokalemia
- Increase in HbA1c
- Fluctuation in plasma tacrolimus level
- Occurrence of gout
Background summary
Calcineurin inhibitors (CNIs) are used in the treatment of psoriasis or eczema,
but their use is complicated by hypertension. At present it is not known what
the best treatment for hypertension is in patients who are on CNIs. Recently it
has been shown that CNIs cause a salt-sensitive form of hypertension that may
therefore be treated with thiazide diuretics.
Study objective
To compare the blood pressure lowering effect of thiazides against calcium
channel blockers in CNI-induced hypertension.
Study design
Randomized cross-over trial.
Intervention
Patients will be randomized to receive chlorthalidone (12.5 mg once daily, if
needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed
titrated to 10 mg once daily).
Study burden and risks
Both amlodipine and chlorthalidon are commonly used to treat hypertension and
have an acceptable and comparable side-effect profile. The 24-hour blood
pressure measurements may be burdensome, but are internationally accepted as
the golden standard for the diagnosis of hypertension and the evaluation of
antihypertensive therapy.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004704-35-NL |
| CCMO | NL39417.078.12 |