Clinical trial: The SAPPHIRE Study (Systolic And Pulse Pressure Hemodynamic Improvement By Restoring Elasticity) (NCT00045981)

Eligibility criteria:
Inclusion Criteria

          -  Men or women at least 50 years of age.

          -  Screening diagnosis of isolated systolic hypertension, defined as systolic blood
             pressure >150 mm Hg and diastolic blood pressure <90 mm Hg (office blood pressure
             measurements) and systolic blood pressure >140 mm Hg (measured by 24-hour ambulatory
             blood pressure monitoring-mean daytime values).

          -  Baseline systolic blood pressure >150 mm Hg and diastolic blood pressure <90 mm Hg
             (office blood pressure measurements).

          -  Patients without left ventricular hypertrophy (LVH) as determined by limited
             echocardiography for LVH (i.e., wall thickness < 1.2 cm).

          -  Patient can complete an informed consent.

        Exclusion Criteria

          -  Patient <50 years of age.

          -  Patients on antihypertensive therapy with changes in dose in the last 1 month prior to
             the entry into the study.

          -  Hb A1c > 9%.

          -  Serum creatinine > 1.7mg/dL.

          -  History of ketoacidosis or uncontrolled diabetes within the last 2 years.

          -  History of congestive heart failure.

          -  History of stroke, or any sequelae of a transient ischemic attack, reversible ischemic
             neurologic defect, or stroke, within the last 12 months.

          -  History of acute myocardial infarction within 6 months prior to entry into the study.

          -  Any significant ECG abnormalities, including second degree AV-block or complete
             AV-block. Any known significant arrhythmia including atrial flutter, ventricular
             tachycardia, WPW-syndrome. Any hemodynamically significant valvular heart disease.

          -  Any significant systemic illnesses or medical condition that could lead to difficulty
             complying with the protocol.

          -  Screening or Baseline liver function tests SGOT and/or SGPT > 2.0 times the upper
             limits of central laboratory normal range.

          -  Use of systemic and/or inhaled corticosteroids (excluding topical corticosteroids).

          -  Any additional condition(s), which in the investigator's opinion would prohibit the
             patient from completing the study, or not be in the best interest of the patient.

          -  Use of any investigational drugs within 30 days prior to screening.

          -  Previous exposure to ALT-711.

          -  Known seropositivity for HIV or hepatitis C, or presence of hepatitis B surface
             antigen.

          -  Pregnancy or active breast-feeding. Female patients of childbearing potential (not
             postmenopausal for at least 5 years or surgically sterilized) must agree not to become
             pregnant during the duration of the study. Specifically, they must agree to use an
             appropriate contraceptive regimen. Acceptable regimens include abstinence, systemic
             hormones, intrauterine devices and barrier methods, such as cervical caps, male or
             female condoms, or diaphragms with concomitant intravaginal spermicide. A barrier
             method must have been used without failure for at least 1 year immediately preceding
             entry into the study.

          -  Positive drug screen.

          -  Necessity to use tobacco or nicotine-containing products, or to consume caffeine-
             containing beverages and/or food, and/or alcohol after midnight prior to clinic visit
             days, until after any evaluations.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? 0