A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD

Phase 4

Completed

• Conditions: Chronic Kidney Disease; Poorly-Controlled Hypertension

• Registration Number: NCT01750294
• Lead Sponsor: Indiana University

Brief Summary

It is estimated that in the United States there are approximately 8 million individuals with moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an important role in the pathogenesis of hypertension in patients with CKD. For this pilot study, the investigators hypothesize that administration of chlorthalidone among patients with moderate to severe CKD will improve blood pressure (BP).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2016-04-06
• Results First Submitted QC: 2016-04-06
• Status Verified: 2016-05
• Results First Posted: 2016-05-10
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Age greater than 18 years.
• Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m2.
• Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring.
• Treated hypertension: 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.

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Exclusion Criteria

• Use of thiazide or thiazide-like drugs in the previous 3 months.
• Use of furosemide in a dose >200 mg/d.
• Ambulatory BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring.
• Expected to receive renal replacement therapy within the next 3 months.
• Vascular event such as myocardial infarction, heart failure hospitalization, or stroke within 3 months prior to randomization.
• 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).
• Known hypersensitivity to thiazide or sulfa drugs.
• Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled corticosteroids will be permitted.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks	Baseline and 12 weeks after intervention

Trial Locations

Locations (1)

Richard L. Roudebush VAMC; 🇺🇸 Indianapolis, Indiana, United States