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
Change in 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 cyclosporine level
- Occurrence of gout
Background summary
Calcineurin inhibitors (CNIs) are routinely used as immunosuppressive drugs
after kidney transplantation and for the treatment of severe cases of psoriasis
or eczema. Unfortunately their use is complicated by hypertension. At present
it is not known what the best treatment for hypertensionin caused by the use of
CNIs is. 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) and amlodipine (5 mg once daily, if needed
titrated to 10 mg once daily) in succession (first drug A, than drug B, or the
other way around). Titration will be applied if the mean arterial pressure
(MAP) is over 105 mmHg during datascope measurements 2 weeks after starting a
new drug.
Study burden and risks
Both amlodipine and chlortalidone are commonly used to treat hypertension and
have an acceptable side-effect profile. The four 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 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
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 | EUCTR2014-000605-12-NL |
| CCMO | NL48221.078.14 |