Spironolactone in CKD Enabled by Chlorthalidone: PILOT

Launched by INDIANA INSTITUTE FOR MEDICAL RESEARCH · Feb 1, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Spironolactone in CKD Enabled by Chlorthalidone: PILOT" is studying how two medications, spironolactone (SPL) and chlorthalidone (CTD), can be used together to help control high blood pressure in patients with chronic kidney disease (CKD). High blood pressure is common in these patients and can lead to more serious health problems, including worsening kidney function and heart disease. This pilot study aims to see if combining SPL, which can raise potassium levels, with CTD, which lowers potassium levels, can effectively control blood pressure without causing dangerous increases in potassium.

To be eligible for this trial, participants should be at least 18 years old and have a specific level of kidney function and high blood pressure. They should also be taking at least one medication for high blood pressure at the time of joining the study. Participants will be monitored over a 12-week period to see how well this combination treatment works and to ensure their potassium levels remain safe. This study is currently recruiting participants at the Richard L. Roudebush VA in Indianapolis, Indiana. If you or someone you know is interested in participating, it’s a good opportunity to contribute to research that could help others with similar health challenges.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age greater than 18 years.
• • 2. GFR estimated by CKD-EPI formula \< 45 ml/min/1.73 m2 but ≥ 15 mL/min/1.73 m2 using IDMS-calibrated creatinine.
• • 3. Hypertension. Using AOBP monitoring, BP of ≥ 130/80 mmHg.
• • 4. Treatment with antihypertensive drugs: This would require the use of at least one antihypertensive drug. One of the drugs should be either an ACE inhibitor or ARB or a beta-blocker at the time of randomization.
• • 5. Serum K 3.5 to 5.2 mEq/L at the time of randomization. In patients with eGFR \< 45 ml/min/1.73 m2 and serum K \> 5.2 mEq/L
• Exclusion Criteria:
• • 1. Use of spironolactone, eplerenone, amiloride, triamterene, thiazides, or thiazide-like drugs or the use of K supplements or K binders in the previous 12 weeks.
• • 2. Expected to receive renal replacement therapy within the next 6 months.
• • 3. Myocardial infarction, heart failure hospitalization, or stroke ≤ 12 weeks prior to randomization.
• • 4. Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
• • 5. Known hypersensitivity to thiazide or spironolactone.
• • 6. Clinic AOBP \<110 mmHg systolic at their first visit