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Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657241
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : July 1, 2010
Information provided by:
State University of New York at Buffalo

Brief Summary:
14-week single blind, double baseline, forced-titration, cross-over comparison of the cardiac benefits of Coreg CR compared to valsartan added to existing ACE inhibition

Condition or disease Intervention/treatment Phase
Hypertension Drug: carvedilol Drug: valsartan Phase 3

Detailed Description:
Combination drug therapy is necessary for optimal blood pressure reduction and current guidelines mandate the concomitant use of ACE inhibitors and β-blockers in most patients at significant risk for cardiovascular disease (CVD) events. There is also continuing interest in combining angiotensin receptor blockers (ARBs) with ACE inhibitors in hypertension based on the unsubstantiated belief that "more complete" renin-angiotensin system inhibition is desirable. It is more attractive physiologically to combine a long-acting β-blocker with vasodilatory actions (Coreg CR) with an ACE inhibitor because this combination addresses more directly the two fundamental hemodynamic changes needed to reduce CVD events: lowering systolic BP (afterload) and lowering heart rate; the product of the two is a reliable surrogate for reduced cardiac work. In fact, clinical trial data suggest that there is no appreciable additional BP lowering when ARBs are added to ACE inhibitors and neither class lowers heart rate. The present proposal is designed to demonstrate the superior "cardioprotection" of Coreg CR compared to ARB (valsartan) when each is added to background ACE inhibitor therapy. Principal dependent variables include ambulatory cardiac work (24-hour mean ambulatory systolic BP x heart rate) and laboratory stress responses (central systolic time-tension indices derived from arterial tonometry pre- and post-bicycle exercise). Secondary hemodynamic variables will define changes in flow and pressure (e.g. central systolic BP and forward and reflected pressure wave estimations).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril
Study Start Date : April 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
Valsartan 160 mg (one week); valsartan 320 mg (3 weeks)
Drug: valsartan
Valsartan 160 mg (one week); valsartan 320 mg (3 weeks)
Other Name: Diovan

Active Comparator: B
Coreg CR 20 mg (one week) and Coreg CR 40 mg (3 weeks).
Drug: carvedilol
Coreg CR 20 mg (one week) and Coreg CR 40 mg (3 weeks).
Other Name: Coreg CR

Primary Outcome Measures :
  1. Difference in resting CTTI (cardiac work) between Coreg and valsartan. [ Time Frame: 3 weeks, 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with residual (uncontrolled) hypertension on lisinopril monotherapy, defined as 24-hour ambulatory diastolic BP >85 mmHg.

Exclusion Criteria:

A subject meeting any of the following conditions will be excluded from the study:

  • History of serious adverse effects with ACE inhibitor, Coreg, or valsartan
  • Known or suspected causes of secondary hypertension (e.g., renovascular stenosis, primary hyperaldosteronism)
  • Known ischemic heart disease requiring beta-blocker therapy (includes angina, prior transmural myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty or stenting within 6 months prior to study entry).
  • Heart failure (NYHA Functional Class II-IV)
  • Obstructive valvular heart disease or obstructive hypertrophic cardiomyopathy
  • Presence of clinically significant ventricular or supraventricular arrhythmias (e.g. atrial fibrillation/flutter), pre-excitation syndrome, second or third degree AV block, other conduction defects necessitating the implantation of a permanent cardiac pacemaker, or sick sinus syndrome.
  • Chronic kidney disease (serum creatinine >2.5 within past 6 months)
  • Uncontrolled diabetes mellitus (i.e., a fasting blood glucose >200 mg/dL [>11.1 mmol/L] or hemoglobin A1c > 10%
  • History of alcohol or other drug abuse within 6 months prior to enrollment
  • Concomitant treatment or probable need for treatment with prohibited medications. NSAIDs, diabetes medications and other chronic meds are permitted if continued throughout study without dosage change.
  • Any other medical condition which renders the subject unable to complete the study or which would interfere with optimal participation in the study or produce a significant risk to the subject
  • Those with persistent systolic BP elevations above 179 mmHg will be discontinued from the study as will those with any significant adverse effect of medication.
  • Positive pregnancy test or failure to practice adequate contraception in women of child-bearing potential
  • Bronchospastic asthma requiring chronic steroid or inhaler therapy
  • Any women with child-bearing potential

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657241

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United States, New York
Erie County Medical Center
Buffalo, New York, United States, 14215
Sponsors and Collaborators
State University of New York at Buffalo
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Principal Investigator: Joseph L Izzo, M.D. SUNY Buffalo
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Joseph L. Izzo, Jr., M.D., SUNY Buffalo Identifier: NCT00657241    
Other Study ID Numbers: 111704
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: June 2010
Keywords provided by State University of New York at Buffalo:
cardiac work
coreg cr
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists