Status:
COMPLETED
Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
ADPKD
Eligibility:
All Genders
20-55 years
Phase:
PHASE3
Brief 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). ...
Detailed Description
Background: Cardiovascular complications are currently the major causes of mortality among patients with autosomal dominant polycystic kidney disease (ADPKD). Therefore, testing valid interventions to...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01853553
Start Date
July 1 2013
End Date
January 1 2017
Last Update
August 20 2019
Active Locations (1)
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1
UColorado
Aurora, Colorado, United States, 80045