The Management of Resistant Hypertension in Kidney Transplant Patients Using Chlorthalidone

NCT02030314 | Withdrawn Phase 4

• 1 other identifier: HM20002960
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Resistant Hypertension in Kidney Transplant Patients

Keywords

Chlorthalidone; Resistant Hypertension; Kidney Transplant Patients

Outcome Measures

Primary Outcomes (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,

  To examine the efficacy of Chlorthalidone as an antihypertensive agent in the treatment of resistant hypertension among stable kidney transplant recipients

  Week 1, week 3, and end of study

Other Outcomes (2)

• Change in urine studies including urine sodium, chloride and calcium using the non-parametric Wilcoxon test

  Week 1, week 3, and end of study

• 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

  Week 1, week 3, and end of study

Study Arms (1)

chlorthalidone, resistant high blood pressure

EXPERIMENTAL

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

Interventions

Chlorthalidone DRUG

treatment of resistant hypertension in kidney transplant patients

Also known as: Thalitone

chlorthalidone, resistant high blood pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealtlh University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

  PMID: 39082471 DERIVED

MeSH Terms

Interventions

Chlorthalidone

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gaurav Gupta, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 8, 2014
• Study Start: July 1, 2013
• Primary Completion: April 12, 2017
• Study Completion: April 12, 2017
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

US (1)