Hypertension Clinical Trial
Official title:
The Vascular Effects of Carvedilol Controlle Release (CR) + Lisinopril Versus Lisinopril + Hydrochlorothiazide (HCTZ) in Abdominally Obese Hypertensive Patients
The purpose of this study is to compare the effects of two different combination therapies for high blood pressure on vascular health.
Hydrochlorothiazide (HCTZ) has been a popular choice for the treatment of hypertension
mainly due to its efficacy in lowering blood pressure, safety, and cost-effectiveness.
Similarly, angiotensin converting enzyme inhibitors (ACE-I), because of their neutral to
positive impact on glycemic control, have been a popular choice for addressing hypertension
in abdominally obese patients. Furthermore, the ACE-I drug class has been shown to improve
vascular endothelial function and inflammation in addition to its blood pressure lowering
effects.
Conversely, beta-adrenergic receptor blockers (b-blockers) have generally been avoided as
first line anti-hypertensive therapy in pre-diabetic patients due to concerns about
worsening glycemic control and potential hastening of progression to type 2 diabetes
mellitus (T2DM). However, recent data have shown that the 3rd generation b-blocker
carvedilol does not negatively affect glucose metabolism and therefore may be a safe and
effective choice for blood pressure control in these patients. This neutral glycemic effect
is likely due to the fact that carvedilol is a non-selective b-receptor antagonist (blocks
both b1 and b2 receptors) with alpha1-receptor blocking properties. In addition, carvedilol
possesses anti-oxidant properties and improves endothelial function, potentially making it
an attractive anti-hypertensive treatment strategy in patients with abdominal obesity.
The combination of carvedilol and lisinopril may be especially effective in reducing blood
pressure and may act synergistically to address the impaired vascular function and increased
inflammation and oxidative stress present in patients with the metabolic syndrome phenotype.
Therefore the primary objective of the current study will be to evaluate the effects of
carvedilol CR + lisinopril compared to lisinopril + HCTZ on vascular function in a head to
head trial in abdominally obese, hypertensive patients. The secondary objective will be to
compare the effects of these two anti-hypertensive therapies on plasma biomarkers of
endothelial activation, inflammation, and oxidative stress in these patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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