Study Stopped
Company decision to stop enrolling not associated with any safety concerns.
ANTHEM-HFrEF Pivotal Study
Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction
1 other identifier
interventional
533
1 country
22
Brief Summary
A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started May 2018
Longer than P75 for not_applicable heart-failure
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2018
CompletedFirst Posted
Study publicly available on registry
February 7, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedOctober 10, 2023
October 1, 2023
5.1 years
January 26, 2018
October 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Event-free rate
The event-free rate, through 90 days after VITARIA implantation, from all VITARIA system-related and VITARIA implantation-related serious adverse events, as adjudicated by the Clinical Events Committee
90 days
Cardiovascular mortality and HF hospitalization
A composite of cardiovascular mortality or heart failure hospitalization, as adjudicated by the Clinical Events Committee, based on time to first event after randomization
Through study completion, an average of 2 years
Study Arms (2)
Therapy
EXPERIMENTALVITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy
Control
NO INTERVENTIONStable guideline-directed medical therapy
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 or above
- Willing and capable of providing informed consent
- Capable of participating in all testing associated with this clinical investigation
- Stable, guideline-directed medical therapy for at least 4 weeks before subject screening. Unrestricted changes in diuretics are allowed during the 4 weeks, as long as the subject remains on a diuretic. If the use of an ARNI is being contemplated for a study subject, ARNI should be administered, and GDMT optimized, before the subject is randomized. No more than a 100% increase or 50% decrease of the dosage of any medication other than a diuretic is permitted. For these medications, medication changes within a class are allowed, as long as the equivalent dosage is within these specified limits
- Stable symptomatic heart failure NYHA class III; or NYHA class II with a heart failure hospitalization in the previous 12 months. HF hospitalization may include an overnight hospital or hospital-based observation unit stay with a primary diagnosis of HF, or an emergency department visit with a primary diagnosis of HF, and will in either case include documentation of intravenous HF therapy administration or other intervention for HF
- Left ventricular ejection fraction (EF) ≤ 35% and left ventricular end-diastolic diameter (LVEDD) \< 8.0 cm, as confirmed by the core echocardiography laboratory during screening
- N-terminal pro-BNP (NT-proBNP) level of at least 800 pg/mL, as determined by the core laboratory; or NT-proBNP level of at least 1200 pg/mL, as determined by the core laboratory, for patients with permanent atrial fibrillation or reporting signs or symptoms of atrial fibrillation at the time that the NT-proBNP sample is drawn
- Received a standard cardiac assessment, including history, physical exam, and electrocardiogram, and determined by a heart failure cardiologist and study surgeon to be an appropriate candidate for the study's surgical procedure
- Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and having a baseline distance of between 150 and 450 meters. Symptoms limiting the duration of the 6 minute walk test must be due primarily to heart failure
You may not qualify if:
- Refractory symptomatic hypotension (systolic blood pressure below 80 mmHg)
- Complete AV block treated with unipolar pacemaker therapy
- Currently implanted vagus nerve stimulation (VNS) device, baroreceptor activation therapy (BAT) device, other nerve stimulator, artificial or donor heart, or ventricular assist device (VAD)
- Heart failure of non-ischemic origin for less than 6 months, or due to congenital heart disease, hypertrophic obstructive cardiomyopathy, or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- Moderate (3+) or severe (4+) aortic valve or mitral valve stenosis; moderate (3+) or severe (4+) aortic valve insufficiency; or severe (4+) mitral valve insufficiency
- Symptomatic uncontrolled bradycardia
- On renal dialysis
- Involvement in any concurrent clinical study with an investigational therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
Study Sites (22)
University of Alabama
Birmingham, Alabama, 35294, United States
University of Arizona
Tucson, Arizona, 85724, United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
Long Beach Memorial Hospital
Long Beach, California, 90806, United States
Greater Los Angeles VA Medical Center
Los Angeles, California, 90073, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256, United States
UnityPoint Health - Methodist Hospital
Peoria, Illinois, 61606, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Lahey Medical Center
Burlington, Massachusetts, 01805, United States
Michigan Heart, PC
Ypsilanti, Michigan, 48197, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Mount Sinai School St. Luke's
New York, New York, 10025, United States
MetroHealth System
Cleveland, Ohio, 44109, United States
ProMedica Northwest Ohio Cardiology Consultants
Toledo, Ohio, 43606, United States
Penn State Health Milton Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Pinnacle Health
Wormleysburg, Pennsylvania, 17043, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (3)
Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1.
PMID: 25187002BACKGROUNDPremchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Extended Follow-Up of Patients With Heart Failure Receiving Autonomic Regulation Therapy in the ANTHEM-HF Study. J Card Fail. 2016 Aug;22(8):639-42. doi: 10.1016/j.cardfail.2015.11.002. Epub 2015 Nov 11.
PMID: 26576716BACKGROUNDKonstam MA, Udelson JE, Butler J, Klein HU, Parker JD, Teerlink JR, Wedge PM, Saville BR, Ardell JL, Libbus I, DiCarlo LA. Impact of Autonomic Regulation Therapy in Patients with Heart Failure: ANTHEM-HFrEF Pivotal Study Design. Circ Heart Fail. 2019 Nov;12(11):e005879. doi: 10.1161/CIRCHEARTFAILURE.119.005879. Epub 2019 Nov 14.
PMID: 31722536DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2018
First Posted
February 7, 2018
Study Start
May 1, 2018
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share