Status:
WITHDRAWN
Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN)
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
American Society for Transplantation
Conditions:
High Blood Pressure
Liver Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Liver transplantation is a high risk, high-cost intervention that extends life in over 8,000 patients in the US each year. Of those that receive transplants, 1 in 3 will have a complication related to...
Detailed Description
The study will involve a randomized crossover trial of two medications: amlodipine besylate 10mg and chlorthalidone 25mg daily by mouth. Amlodipine was selected as the dihydropyridine calcium channel ...
Eligibility Criteria
Inclusion
- Liver transplant alone recipient
- At least 90 days from transplant
- Average daytime systolic blood pressure (SBP)\>140mmHG with 24h ambulatory blood pressure monitoring. Patients will be enrolled in 24h ambulatory blood pressure monitoring (ABPM) if they have hypertension (HTN) defined by diagnostic codes, treatment with antihypertensive medications for ≥ 2 months, and a history of office blood pressure readings ≥140/90 mmHg at two separate office visits.
- Stable antihypertensive medical therapy (e.g., no change in current antihypertensive medications within 30d of screening)
- No acute cellular rejection within 30d of screening
Exclusion
- Contraindication to withholding calcium channel blockers (CCB) or beta-blocker (e.g., atrial fibrillation/flutter)
- Treatment with other diuretics that cannot be held
- Acute coronary syndrome or revascularization within 60d
- Serum potassium \< 3.5 mEq/L
- Serum sodium \< 135 mg/dL
- Allergy to sulfa drugs
- Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 or on dialysis
- Pregnant women
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05275907
Start Date
July 12 2022
End Date
October 4 2023
Last Update
October 13 2023
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611