Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Management of Resistant Hypertension in Kidney Transplant Patients Using Chlorthalidone

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.
ClinicalTrials.gov Identifier: NCT02030314
Recruitment Status : Withdrawn (The patient population changed. Unable to find patients that meet study criteria)
First Posted : January 8, 2014
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:

Chlorthalidone might offer an effective, safe and inexpensive anti-hypertensive treatment for kidney transplant patients who have resistant hypertension on multi-drug therapy. We will collect initial data on the safety and efficacy of Chlorthalidone in the treatment of patients with resistant hypertension.

To Examine the efficacy of chlorthalidone as an anti-hypertensive agent in the treatment of resistant hypertension among stable kidney transplant recipients


Condition or disease Intervention/treatment Phase
Resistant Hypertension in Kidney Transplant Patients Drug: Chlorthalidone Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Management of Resistant Hypertension in Kidney Transplant Patients Using Chlorthalidone
Study Start Date : July 2013
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: chlorthalidone, resistant high blood pressure
if Furosemide dose is 40 mg per day, start Chlorthalidone 12.5 mg per day if Furosemide dose is 80 mg per day, start Chlorthalidone 25 mg per day
Drug: Chlorthalidone
treatment of resistant hypertension in kidney transplant patients
Other Name: Thalitone




Primary Outcome Measures :
  1. Change from mean baseline systolic blood pressure (by ABPM) between week 0, 1 and 7, ANOVA ABPM at baseline, week 1 and end of the study, Least-squares mean and standard error of the mean for changes in blood pressure measures, [ Time Frame: Week 1, week 3, and end of study ]
    To examine the efficacy of Chlorthalidone as an antihypertensive agent in the treatment of resistant hypertension among stable kidney transplant recipients


Other Outcome Measures:
  1. Change in urine studies including urine sodium, chloride and calcium using the non-parametric Wilcoxon test [ Time Frame: Week 1, week 3, and end of study ]
    To examine the efficacy and safety of Chlorthalidone as an antihypertensive agent tin the treatment of resistant hypertension among stable kidney transplant recipients

  2. Adverse events requiring interventions Hypokalemia (K<3meq/L) Hypokalemia (Na<130meq/L r Na<135meq/L accompanied by symptoms, symptomatic Hypotension, rise in serum Creatinine and blood urea nitrogen >2x baseline [ Time Frame: Week 1, week 3, and end of study ]
    To examine the safety of Chlorthalidone as an antihypertensive agent tin the treatment of resistant hypertension among stable kidney transplant recipients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Agree to participate in study
  2. Patients after kidney transplantation> 6 months post-transplant.
  3. Age>18 years
  4. Home or office Systolic Blood pressure >140 confirmed with daytime 24-h ABPM of average systolic blood pressure >140.
  5. Tacrolimus/Cyclosporine therapy with therapeutic trough level based upon historical values
  6. Stable renal function for at least 3 months before enrollment.
  7. Historical Baseline estimated Glomerular Filtration Rate >30mL/min
  8. No more than trace edema on physical examination at time of initial assessment.
  9. Receiving optimal doses of ≥ 3 anti-hypertensive medications including furosemide at ≤80mg/d.9.
  10. 8-10 in morning sitting Plasma aldosterone Concentration < 15ng/dL and Plasma Renin Activity <0.6ng/mL/h

Exclusion Criteria:

  1. Serum sodium<135meq/L based upon historical values
  2. Serum potassium<3.5meq/L based upon historical values
  3. Poorly controlled diabetes mellitus with HbA1c>9% based upon historical values
  4. Already on thiazide
  5. Arm circumference >42cm
  6. Clinically significant hepatic dysfunction based upon medical history or historical values
  7. Two (2) Unsuccessful baseline ABPMs
  8. Poor adherence in run-in period as suggested by an unsuccessful 24-h urine collection.
  9. DBP≥110 or SBP≥200
  10. Allergy to Chlorthalidone

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): NCT02030314


Locations
Layout table for location information
United States, Virginia
Virginia Commonwealtlh University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Layout table for investigator information
Principal Investigator: Gaurav Gupta, MD Virginia Commonwealth University

Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02030314     History of Changes
Other Study ID Numbers: HM20002960
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017

Keywords provided by Virginia Commonwealth University:
Chlorthalidone
Resistant Hypertension
Kidney Transplant Patients

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chlorthalidone
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action