Hypertension Clinical Trial
Official title:
Comparison of Single and Combination Diuretics in Low-Renin Hypertension
The purpose of this study is to determine whether the routine combination of optimal thiazide and K+-sparing diuretic will both increase efficacy of BP reduction and reduce risk of glucose intolerance; and whether K+-sparing diuretics alone may have a neutral or even beneficial effect upon glucose tolerance.
A major attraction of K+-sparing diuretics may be the absence of risk of new-onset diabetes
(DM). Since they have not been compared in hypertension outcome trials, and DM has not been
an endpoint in heart failure studies of spironolactone or eplerenone, we do not know for
certain whether they are clean in this respect. Short-term studies suggest they are.49
Interestingly in INSIGHT there was no excess of DM in patients receiving HCTZ 25mg, which
was combined with amiloride 2.5mg, but increased by 30% in patients on HCTZ/amiloride
50/5mg.44 In the proposed study we shall use the oral glucose tolerance test (OGTT) to
provide an endpoint for each subject. This strategy has recently been employed to
demonstrate a difference after just 12 weeks of dosing with a thiazide diuretic50.
Hyperkalaemia has been the traditional concern about K+-sparing diuretics. We expect to
demonstrate that in patients with eGFR ≥45, the risk of hyperkalaemia is nullified by
combination with a thiazide. Instead then of amiloride being used mainly in trace doses to
balance the hypokalaemia of thiazides, practice might reverse to thinking of thaizides as
the "partner" used to negate risk of hyperkalaemia.
The challenge to designing this study is to compare several options among the diuretics
while achieving clear cut answers to:
1. the comparison of combination with single diuretics and
2. the comparison of K+-sparing diuretics with thiazide.
A study of sufficient duration to establish efficacy and tolerability (especially upon
glucose tolerance) cannot be crossover in design and therefore requires a large number of
subjects to compare the options. In order to maximize recruitment whilst also maximizing
sensitivity to detect changes in OGTT, we will open the trial to most of those patients with
hypertension in whom diuretic is a reasonable next option, providing they have one feature
of the metabolic syndrome - additional to hypertension.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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