Table 1.

Inclusion and exclusion criteria for enrollment into HALT study A and B

Inclusion Criteria
    Age 15 to 49 yr for study A; age 18 to 64 yr for study B
    GFR > 60 ml/min per 1.73 m2, equated from serum creatinine using the four-variable MDRD equation (study A), GFR 25 to 60 ml/min per 1.73 m2, equated from serum creatinine using the four-variable MDRD equation (study B)
    Hypertension or high–normal blood pressure
    Informed consent.
Exclusion Criteria
  1. Documented renal vascular disease

  2. Spot urine albumin-to-creatinine ratio of≥0.5 (study A) or 1.0 (study B), and/or findings suggestive of kidney disease other than ADPKD

  3. Diabetes requiring insulin or oral hypoglycemic agents or a fasting serum glucose of ≥126 mg/dl or a random nonfasting glucose of ≥200 mg/dl (in accordance with ADA recommendations for diagnosis of diabetes)

  4. Currently pregnant or intention of becoming pregnant throughout the duration of study

  5. Serum potassium >5.5 mEq/L for participants currently on ACEi or ARB therapy; >5.0 mEq/L for participants not currently on ACEi or ARB therapy

  6. History of angioneurotic edema or other absolute contraindication with ACEi or ARB. Intolerable cough associated with ACEi has been defined as cough that developed within 6 mo of initiation of ACEi in the absence of other causes and resolved on discontinuation of the ACEi

  7. Indication (other than hypertension) for β-blocker or calcium channel blocker therapy (e.g., angina, past myocardial infarction, arrhythmia), unless approved by the site principal investigator

  8. Systemic illness necessitating NSAIDs, immunosupressant, or immunomodulatory medications

  9. Systemic illness with renal involvement

  10. Hospitalization for an acute illness in past 2 mo (not including elective admissions)

  11. Life expectancy <2 yr

  12. History of noncompliance, drug, or alcohol dependence within the past year or other psychiatric disturbance that would preclude successful completion of the study

  13. Known presence of unclipped cerebral aneurysm ≥7 mm in diameter

  14. Treatment within the past 30 days on an interventional study

  15. Creatinine supplements within 3 mo before the screening visit

  16. Congenital absence of a kidney or history of a total nephrectomy. A history of cyst reduction or aspiration procedures or partial nephrectomy will not preclude participation in study B