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Completed

NCT Number: NCT01750294

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).

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Key information

Conditions

Chronic Kidney Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Poorly-Controlled Hypertension Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Richard L. Roudebush VAMC

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorthalidone

Drug

Primary outcomes

  1. Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks

    Time frame: Baseline and 12 weeks after intervention

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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