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Comparison of Single and Combination Diuretics in Low-Renin Hypertension (PATHWAY3)
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.
Details
| Lead sponsor | University of Cambridge |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 423 |
| Start date | 2009-11 |
| Completion | 2015-08 |
Conditions
- Hypertension
Interventions
- Hydrochlorthiazide
- Amiloride
- Hydrochlorthiazide and Amiloride
Primary outcomes
- Blood glucose measured two hours after oral ingestion of a 75 G glucose drink, following overnight fasting. — 0, 12 and 24
There will be hierarchical co-primary endpoints. First, the primary outcome (2hr glucose) will be compared between the amiloride and HCTZ cohorts. If amiloride is superior, a second primary analysis will compare cohorts on combination therapy and HCTZ. The analyses will adjust for baseline covariates. The difference in blood glucose, over the 6 months between baseline and the end of the study period, measured two hours after oral ingestion of a 75 g glucose drink, will be analysed using a mixed model with patients as a random effect. The model will include terms for gender, age, height, weight and smoking history.
Countries
United Kingdom