Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure (ALLEVIATE-HF)
Heart Failure NYHA Class II, Heart Failure NYHA Class III
About this trial
This is an interventional treatment trial for Heart Failure NYHA Class II focused on measuring Heart Failure, Insertable Cardiac Monitor
Eligibility Criteria
Inclusion Criteria:
- Patient has NYHA Class II or III heart failure per most recent assessment, irrespective of left ventricular ejection fraction (LVEF)
- Patient has documented recent history of symptomatic heart failure, defined as meeting any one of the following three criteria: 1. Hospital admission with primary diagnosis of HF within the last 12 months, OR 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration within the last 6 months, OR 3. Patient had the following BNP/NT-proBNP within the last 3 months: If LVEF ≥ 50%, then BNP> 150 pg/ml or NT-proBNP > 450 pg/ml OR If LVEF is <50%, then BNP> 300 pg/ml or NT-proBNP > 900 pg/ml
- Patient is willing and able to comply with the protocol, including LINQ ICM insertion, CareLink transmissions (including adequate connectivity), study visits and remote care directions.
- Patient is 18 years of age or older.
- Patient has a life expectancy of 12 months or more.
Exclusion Criteria:
- Patient is currently implanted with a cardiovascular implantable electronic device (CIED) (e.g. ICM, pacemaker, ICD, CRT-D or CRT-P device) or hemodynamic monitor.
- Patient is receiving temporary or permanent mechanical circulatory support.
- Patient had MI or PCI/CABG within past 90 days.
- Patient has had a heart transplant, or is currently on heart transplant list.
- Patient has severe valve stenosis on echocardiogram.
- Patient has primary pulmonary hypertension (pre-capillary, WHO group 1,3,4,5).
- Patient is on chronic intravenous inotropic drug therapy (e.g. dobutamine, milrinone).
- Patient has severe renal impairment (eGFR <30 mL/min).
- Patient has systolic blood pressure of < 90 mmHg at the time of enrollment.
- Patient is on chronic renal dialysis.
- Patient is unable to undergo one round of PRN medication intervention (i.e. 4 days of increased diuretics dose).
- Patient has liver disease, defined as AST/ALT >5x normal, or bilirubin >2x normal.
- Patient has serum albumin < 3 g/dL.
- Patient has hypertrophic obstructive cardiomyopathy, constrictive pericarditis or amyloidosis.
- Patient has complex adult congenital heart disease.
- Patient has active cancer involving chemotherapy and/or radiation therapy.
- Patient weighs more than 500 pounds.
- Patient is pregnant or breastfeeding (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment).
- Patient is enrolled in another interventional study.
Sites / Locations
- Cardiovascular Associates of MesaRecruiting
- Arrhythmia Research GroupRecruiting
- Saint Joseph Heritage Healthcare
- Cardiology Associates Medical GroupRecruiting
- Saint Joseph's Medical CenterRecruiting
- South Denver Cardiology AssociatesRecruiting
- FWD Clinical Research LLCRecruiting
- Bay Area Cardiology Associates PARecruiting
- Florida Heart CenterRecruiting
- Baptist HealthRecruiting
- First Coast Cardiovascular Institute PARecruiting
- Citrus Cardiology Consultants PARecruiting
- Baptist HospitalRecruiting
- Northside HospitalRecruiting
- Tallahassee Research InstituteRecruiting
- Memorial Health University Medical CenterRecruiting
- NorthShore University Health SystemRecruiting
- Carle Foundation Hospital
- Parkview HealthRecruiting
- Ascension Medical Group - Saint VincentRecruiting
- Iowa Heart Center
- University of Kansas Medical CenterRecruiting
- Saint Elizabeth HealthcareRecruiting
- Baptist Healthcare SystemRecruiting
- Norton HealthcareRecruiting
- Advanced Cardiovascular Specialists
- North Memorial Health Heart & Vascular CenterRecruiting
- University of Mississippi Medical CenterRecruiting
- Cardiology Associates of North MississippiRecruiting
- Missouri Cardiovascular Specialists
- CHI Health Nebraska Heart
- CHI Health Creighton University Medical Center - Bergan MercyRecruiting
- Lourdes Cardiology ServicesRecruiting
- New Mexico Heart Institute PARecruiting
- New York-Presbyterian Brooklyn Methodist HospitalRecruiting
- Columbia University Irving Medical Center/NYPHRecruiting
- Hudson Valley Heart CenterRecruiting
- Saint Francis HospitalRecruiting
- Stony Brook University HospitalRecruiting
- Cone Health
- Novant Health New Hanover Regional Medical CenterRecruiting
- The Lindner Research CenterRecruiting
- Mount Carmel EastRecruiting
- OhioHealth Research and Innovation Institute (OHRI)Recruiting
- Doylestown Health Cardiology a division of Doylestown Health PhysiciansRecruiting
- Cardiology Consultants of PhiladelphiaRecruiting
- Medical University of South CarolinaRecruiting
- Prisma Health MidlandsRecruiting
- The Stern Cardiovascular FoundationRecruiting
- University of Tennessee Methodist PhysiciansRecruiting
- Medical City Fort WorthRecruiting
- Tyler Cardiovascular ConsultantsRecruiting
- University of Virginia Medical Center
- Sentara Norfolk General HospitalRecruiting
- Swedish Medical Center Cherry HillRecruiting
- Saint Joseph Medical Center (Tacoma WA)Recruiting
- Charleston Area Medical Center (CAMC) Memorial HospitalRecruiting
- West Virginia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Observation Arm
Intervention Arm
Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects will transition to the intervention arm after 13 months.
Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan.