Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Abatacept; Placebo
Intervention description: All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day [Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.; All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day [Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hypertension; inflammation

Summary:

      The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug
      Administration to treat rheumatoid arthritis, may help blood pressure medications to work
      better. This will be studied in people with high blood pressure that is not well controlled
      on three or more blood pressure medications, the condition also known as resistant
      hypertension. We expect to show that adding abatacept therapy to standardized treatment of
      resistant hypertension will result in a greater decrease in blood pressure at 24 weeks
      compared to treatment with placebo and conventional blood pressure treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women 18 to 65 years of age with hypertension, treated with three or more
             anti-hypertensive drugs, one being a diuretic, and

          -  having a systolic blood pressure >150 mmHg in the clinic and daytime average >150 mmHg
             on ambulatory blood pressure monitoring

        Exclusion Criteria:

          -  Medical history of secondary cause of hypertension, severe obesity (BMI >35), severe
             psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell
             cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before

          -  Inability to return for abatacept treatment and follow-up for 24 weeks.

          -  Inability to understand or complete study-related assessments.

          -  Current abuse of drugs or alcohol.

          -  Receipt of any live vaccines within 3 months of the anticipated first dose of study
             medication.

          -  Evidence of active or latent bacterial or viral infections at the time of potential
             enrollment, including human immunodeficiency virus (HIV)

          -  Risk for tuberculosis

          -  Abnormal laboratory values including positive hepatitis B surface antigen, hemoglobin
             < 8.5 g/dL, white blood cell count < 3000/mm3, platelets < 100,000/mm3, creatinine >
             2.5 times the upper limit of normal (ULN), alanine aminotransferase or aspartate
             aminotransferase > 2 times the ULN.