Status:
WITHDRAWN
Sacubitril-valsartan Versus Usual Anti-hypertensives in LVAD
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Medtronic
Conditions:
Congestive Heart Failure
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This pilot, feasibility study evaluates the efficacy of sacubitril-valsartan (Entresto) versus usual anti-hypertensive medications in patients with left ventricular assist devices (LVAD). It also meas...
Detailed Description
Left ventricular assist devices (LVAD) have become a life-saving therapy for patients with ACC/AHA stage D congestive heart failure (CHF). Despite longevity and improved quality of life, LVAD-supporte...
Eligibility Criteria
Inclusion
- More than 30 days after LVAD implant
- Ambulatory
- MAP \> 85 mmHg requiring initiation of anti-hypertensive medications
Exclusion
- Allergy to ACEI or ARB
- eGFR \< 30 mL/min/1.73m2
- K \> 5.4 mmol/L
- MAP \< 60
- Inability to check blood pressure at home
- Lack of prescription coverage
- Frequent hospitalizations (monthly)
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03279861
Start Date
November 1 2017
End Date
November 1 2019
Last Update
May 6 2023
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