Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Completed · Phase 3 · Has a placebo group

Conditions studied: ADPKD

In brief

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.

Key facts

Study ID

NCT01853553

Run by

University of Colorado, Denver

People needed

61

Starts

2013-07-01

Expected to finish

2017-01-01

Last updated by the study team

2019-08-20

Who can join

Age: 20 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• • 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

Where it is running

• UColorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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