The Management of Resistant Hypertension in Kidney Transplant Patients Using Chlorthalidone

• Status: Withdrawn
• Trial end date: 2017-04-12
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Chlorthalidone

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