Sacubitril-valsartan Versus Usual Anti-hypertensives in LVAD
Primary Purpose
Congestive Heart Failure, Hypertension
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Entresto
Valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria:
- More than 30 days after LVAD implant
- Ambulatory
- MAP > 85 mmHg requiring initiation of anti-hypertensive medications
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Entresto
Usual meds
Arm Description
First-line anti-hypertensive: sacubitril-valsartan, starting at 24-26 mg twice daily, increasing to maximum dose of 97-103 mg twice daily
First-line anti-hypertensive: valsartan, starting at 40 mg twice daily, increasing to a maximum dose of 160 mg twice daily
Outcomes
Primary Outcome Measures
Time spent with MAP < 85 mmHg
Daily mean arterial pressure (MAP) < 85 mmHg
Secondary Outcome Measures
Number of drugs
Number of anti-hypertensive drugs needed to achieve MAP < 85 mmHg
Pump flow
Correlation of pump flow with daily MAP
Full Information
NCT ID
NCT03279861
First Posted
September 8, 2017
Last Updated
May 4, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT03279861
Brief Title
Sacubitril-valsartan Versus Usual Anti-hypertensives in LVAD
Official Title
Sacubitril-valsartan (Entresto) Versus Standard Anti-hypertensive Therapy in LVAD Patients - A Feasibility Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
protocol change
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 measures diurnal blood pressure variations in the context of continuous flow physiology.
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-supported patients are plagued with adverse events, the most debilitating of all is stroke. Ischemic and hemorrhagic strokes have been associated with hypertension (mean arterial pressure, or MAP > 90 mmHg) in addition to out-of-range INR and aspirin doses. Strict blood pressure control has been shown in a recent randomized trial to confer a significant decline in stroke rates of patients implanted with the Heartware LVAD. Patients with poorly controlled hypertension are also at risk for inadequate left-ventricular unloading and worsening CHF due to the exquisite sensitivity to afterload of the continuous flow LVAD.
There are no guidelines for the use of anti-hypertensives in LVAD patients. Most are started on standard CHF therapies, though this practice varies greatly across LVAD centers. The angiotensin receptor blocker-neprilysin inhibitor sacubitril-valsartan (Entresto) is a potent anti-hypertensive mediation that was recently approved by the Food and Drug Administration for the treatment of patients with heart failure and low ejection fraction. We aim to randomly assign patients to receive Entresto or usual anti-hypertensive therapy for blood pressure control, then crossover to the other arm after 30 days. Daily blood pressure measurements will be performed and correlated with LVAD pump flows and waveform analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Entresto
Arm Type
Active Comparator
Arm Description
First-line anti-hypertensive: sacubitril-valsartan, starting at 24-26 mg twice daily, increasing to maximum dose of 97-103 mg twice daily
Arm Title
Usual meds
Arm Type
Active Comparator
Arm Description
First-line anti-hypertensive: valsartan, starting at 40 mg twice daily, increasing to a maximum dose of 160 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Entresto
Intervention Description
First line therapy in Entresto arm
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Description
First line therapy in "usual meds" arm
Primary Outcome Measure Information:
Title
Time spent with MAP < 85 mmHg
Description
Daily mean arterial pressure (MAP) < 85 mmHg
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Number of drugs
Description
Number of anti-hypertensive drugs needed to achieve MAP < 85 mmHg
Time Frame
2 months
Title
Pump flow
Description
Correlation of pump flow with daily MAP
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 30 days after LVAD implant
Ambulatory
MAP > 85 mmHg requiring initiation of anti-hypertensive medications
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Van-Khue Ton, MD PhD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sacubitril-valsartan Versus Usual Anti-hypertensives in LVAD
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