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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750294
First Posted: December 17, 2012
Last Update Posted: June 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana University
  Purpose
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).

Condition Intervention Phase
Chronic Kidney Disease Poorly-Controlled Hypertension Drug: Chlorthalidone Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks [ Time Frame: Baseline and 12 weeks after intervention ]

Enrollment: 14
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750294


Locations
United States, Indiana
Richard L. Roudebush VAMC
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Rajiv Agarwal, MD FASN FAHA Indiana University
  More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01750294     History of Changes
Other Study ID Numbers: 1206009002
1206009002 ( Other Identifier: IRB )
First Submitted: December 12, 2012
First Posted: December 17, 2012
Results First Submitted: April 6, 2016
Results First Posted: May 10, 2016
Last Update Posted: June 13, 2016
Last Verified: May 2016

Keywords provided by Indiana University:
hypertension
kidney disease

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Chlorthalidone
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action