Chlorthalidone in Chronic Kidney Disease
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/26/2019 |
| Start Date: | July 2016 |
| End Date: | January 2022 |
| Contact: | Rajiv Agarwal, MD |
| Email: | ragarwal@iu.edu |
| Phone: | 317-988-2241 |
It is estimated that in the United States there are approximately 8 million individuals who
have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and
is often poorly controlled due to an expanded volume state; diuretics are frequently
prescribed. Loop diuretics are potent and effective in lowering blood pressure (BP) but their
use is associated with acute kidney injury. Thiazide diuretics, on the other hand, are less
potent, their use may be associated with less acute kidney injury, but as yet there are no
firm data to support that thiazide diuretic therapy can improve BP among subjects with
advanced CKD. The investigators found 13 studies on the use of thiazide diuretics in advanced
CKD either alone or in combination with loop diuretics and concluded that thiazides may be
useful. Thiazides cause a negative Na balance, increase Na excretion by 10-15% and weight
loss by 1-2 kg in observational studies. Observational data show that thiazides lead to an
improvement in seated clinic BP of about 10-15 mmHg systolic and 5-10 mmHg diastolic whereas
randomized trials show about a 15 mmHg reduction in mean BP. Randomized trials had only
between 7 and 23 subjects each; accordingly, larger studies are needed to evaluate their
safety and efficacy in moderate to advanced CKD.
have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and
is often poorly controlled due to an expanded volume state; diuretics are frequently
prescribed. Loop diuretics are potent and effective in lowering blood pressure (BP) but their
use is associated with acute kidney injury. Thiazide diuretics, on the other hand, are less
potent, their use may be associated with less acute kidney injury, but as yet there are no
firm data to support that thiazide diuretic therapy can improve BP among subjects with
advanced CKD. The investigators found 13 studies on the use of thiazide diuretics in advanced
CKD either alone or in combination with loop diuretics and concluded that thiazides may be
useful. Thiazides cause a negative Na balance, increase Na excretion by 10-15% and weight
loss by 1-2 kg in observational studies. Observational data show that thiazides lead to an
improvement in seated clinic BP of about 10-15 mmHg systolic and 5-10 mmHg diastolic whereas
randomized trials show about a 15 mmHg reduction in mean BP. Randomized trials had only
between 7 and 23 subjects each; accordingly, larger studies are needed to evaluate their
safety and efficacy in moderate to advanced CKD.
This is a two-center, placebo-controlled, double-blind, randomized controlled trial of
chlorthalidone (CTD) in patients with CKD and poorly controlled hypertension
chlorthalidone (CTD) in patients with CKD and poorly controlled hypertension
Inclusion Criteria:
1. Age greater than 18 years.
2. Calculated glomerular filtration rate (GFR) by 4-component Modification of Diet in
Renal Disease (MDRD) formula < 30 ml/min/1.73m2 but ≥15 mL/min/1.73m2. The hospital
laboratory uses isotope dilution mass spectrometry (IDMS) calibrated creatinine and
the appropriate formula is used to estimate GFR.
3. Hypertension. This is defined as BP of either ≥130 systolic or ≥80 mmHg by 24-hour
ambulatory BP monitoring.
4. Treatment with antihypertensive drugs: This would require the use of at least one
antihypertensive drug. One of the drugs should be either an angiotensin converting
enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). If these are
contraindicated then use of a beta-blocker is required prior to randomization.
Exclusion Criteria:
1. Use of thiazide or thiazide-like drugs in the previous 12 weeks.
2. Use of furosemide in a dose >200 mg/d.
3. BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring.
4. Expected to receive renal replacement therapy within the next 3 months.
5. Myocardial infarction, heart failure hospitalization, or stroke ≤3 months prior to
randomization.
6. 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).
7. Known hypersensitivity to thiazide or sulfa drugs.
8. Organ transplant recipient or therapy with immunosuppressive agents.
We found this trial at
1
site
340 West 10th Street
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Principal Investigator: Rajiv Agarwal, MD
Phone: 317-988-2241
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