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| Sponsors and Collaborators: |
St. Paul Heart Clinic GlaxoSmithKline |
|---|---|
| Information provided by: | St. Paul Heart Clinic |
| ClinicalTrials.gov Identifier: | NCT00459056 |
Purpose
The purpose of this study is to compare the effects of two different combination therapies for high blood pressure on vascular health.
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Obesity Hypertension |
Drug: carvedilol cr, lisinopril, hydrochlorothiazide Drug: carvedilol CR + lisinopril |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | The Vascular Effects of Carvedilol CR + Lisinopril Versus Lisinopril + Hydrochlorothiazide in Abdominally Obese Hypertensive Patients |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
carvedilol CR + lisinopril
|
Drug: carvedilol CR + lisinopril
oral tablet with varying doses based upon blood pressure response
|
|
2: Active Comparator
lisinopril + HCTZ
|
Drug: carvedilol cr, lisinopril, hydrochlorothiazide
oral tablets of varying doses based upon blood pressure response
|
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 a1-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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| St. Paul Heart Clinic | Recruiting |
| St. Paul, Minnesota, United States, 55102 | |
| Contact: Janice Downing 651-726-2716 jdowning@stphc.com | |
| Principal Investigator: Aaron S Kelly, PhD | |
| Principal Investigator: | Aaron S Kelly, PhD | St. Paul Heart Clinic |
More Information
| Responsible Party: | St. Paul Heart Clinic ( St. Paul Heart Clinic ) |
| Study ID Numbers: | SPHC 2007-01 |
| Study First Received: | April 10, 2007 |
| Last Updated: | April 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00459056 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Lisinopril Diuretics Sodium Chloride Symporter Inhibitors Vascular Diseases Overweight Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Protease Inhibitors Body Weight Signs and Symptoms Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Nutrition Disorders Adrenergic Antagonists Overnutrition Hypertension Carvedilol |
|
Vasodilator Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Cardiotonic Agents Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Overweight Body Weight Membrane Transport Modulators Signs and Symptoms Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Nutrition Disorders |
Adrenergic beta-Antagonists Cardiovascular Diseases Carvedilol Obesity Lisinopril Vascular Diseases Enzyme Inhibitors Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Protective Agents Hydrochlorothiazide Pharmacologic Actions Protease Inhibitors Natriuretic Agents |
