Hypertension Clinical Trial
Official title:
Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus
Background: Calcineurin inhibitors (CNIs) are the most commonly used immunosuppressive drugs
to prevent rejection after kidney transplantation. However, the efficacy of preventing
rejection comes at the cost of important side-effects. Among the most common side-effects is
hypertension. Hypertension after kidney transplantation is clinically relevant, because it
increases the risk of cardiovascular disease and is associated with increased graft loss and
recipient mortality. The mechanism of CNI-induced hypertension is incompletely understood
and, therefore, the treatment is currently empiric. These and other investigators recently
showed that CNIs cause salt-sensitive hypertension by activating a sodium transporter in the
kidney, namely the thiazide-sensitive sodium chloride cotransporter.
Hypothesis: The investigators hypothesize that thiazide diuretics are non-inferior to
calcium channel blockers (CCBs) (currently usually the treatment of choice) for the
treatment of CNI-induced hypertension.
Objective: To compare the blood pressure response to thiazide diuretics and CCBs in patients
with CNI-induced hypertension.
Study design: Single-center, randomized cross-over trial.
Study population: Kidney transplant recipients with a good functioning allograft (eGFR > 30
ml/min) who are hypertensive (daytime systolic blood pressure > 140 mm Hg) and who do not
have proteinuria (< 1 g/day).
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).
Main study parameters/endpoints: 24-hour blood pressure recording.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Both drugs have long been registered for the treatment of hypertension. The
side-effect profile of both drugs is considered to be equal. The burden of the study for the
patients are blood pressure measurements using 30-minute automated blood pressure
measurement and 24-hour ambulatory blood pressure measurement.
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