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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Poorly-Controlled Hypertension
• Intervention / Treatment: Drug: Chlorthalidone

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Richard L. Roudebush VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks	Baseline and 12 weeks after intervention

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Rajiv Agarwal, MD FASN FAHA, Indiana University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): June 13, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: hypertension; kidney disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Renal Insufficiency; Hypertension; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Chloride Symporter Inhibitors; Chlorthalidone
• Other Study ID Numbers: 1206009002 (Other Identifier: IRB)