Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Carvedilol CR; Valsartan
Intervention MeSH terms: Valsartan; Carvedilol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Run-in period with lisinopril is followed by random entry into valsartan followed by carvedilol CR or carvedilol CR followed by valsartan
Masking: Single (Participant)
Masking description: Drugs names omitted on patient bottles
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: cardiac work; carvedilol CR; valsartan; tonometry

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
    

Eligibility criteria:

        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