Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: ADPKD
MeSH terms: Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Spironolactone; Sugar pill
Intervention description: Blood pressure medication.; Placebo.
Intervention MeSH terms: Spironolactone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The proposed research will determine the effectiveness of blocking aldosterone for improving
      the health and function of arteries in patients with autosomal dominant polycystic kidney
      disease (ADPKD). The study also will provide insight into how blocking aldosterone improves
      artery health by determining the physiological mechanisms (biological reasons) involved.
      Overall, the proposed research will provide important new scientific evidence upon which
      physicians can base recommendations to patients with ADPKD to decrease risk of developing
      cardiovascular diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 20-55 years;

          -  Adults with ADPKD diagnosis based on Ravine criteria aged ≥ 30 years

          -  Estimated glomerular filtration rate ≥ 60 ml/min/1.73m2

          -  Hypertension defined as a systolic BP > 130 mm Hg and/or diastolic BP > 80 mmHg based
             on 3 separate measurements within the past year and currently on a minimum dose of an
             angiotensin converting enzyme inhibitor (minimum dose 10 mg P.O qd) or angiotensin
             receptor blocker (i.e., Losartan 25 mg P.O qd)

          -  If using antioxidants and/or omega-3 fatty acids, must discontinue 4 weeks prior to
             participation

          -  Free from alcohol dependence or abuse

          -  Mini-mental state examination score ≥ 24; ability to provide informed consent

          -  BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)

          -  Not taking medications that interact with agents administered during experimental
             sessions (e.g., sildenafil interacts with nitroglycerin)

        Exclusion Criteria:

          -  • Average serum potassium >5.5 millequivalents or any single serum potassium > 6.0
             millequivalents within the previous 6 months

               -  Receiving an aldosterone antagonist within the previous 6 months

               -  Use of a potassium sparing diuretic or any other drug that could contribute to
                  hyperkalemia

               -  Uncontrolled hypertension

               -  Current smokers or history of smoking in the past 12 months

               -  History of liver disease

               -  History of heart failure (EF < 35%)

               -  History of hospitalizations within the last 3 months

               -  Active infection or antibiotic therapy

               -  Warfarin use

               -  Immunosuppressive therapy within the last year

               -  Pregnancy