What side effects are associated with this type of intervention?

Common treatments for heart failure, particularly those involving diagnostic-based risk stratification and implantable devices like the Reveal LINQ™ system, can have side effects including infection at the implantation site, bleeding, and device-related complications such as lead dislodgement or malfunction. Patients may also experience discomfort or pain at the site of the device. Broader heart failure treatments, such as medications, can cause dizziness, fatigue, hypotension, and electrolyte imbalances.

What prior FDA approvals exist?

The FDA has approved various treatments for heart failure, including medications like ACE inhibitors, beta-blockers, and diuretics, which manage symptoms and improve heart function. More recently, device-based therapies such as implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) have been approved to manage heart failure by monitoring and correcting heart rhythms. The Reveal LINQ™ system, currently under investigation, represents a novel approach by using an integrated device diagnostic-based risk stratification algorithm to guide patient care, potentially enhancing the management of heart failure through continuous monitoring and early detection of cardiac events.

What other types of research exist?

Promising novel alternatives to the Reveal LINQ™ system for heart failure patients include: 1) Advanced wearable cardiac monitors that provide continuous real-time data and integrate with electronic health records for comprehensive patient management. 2) AI-driven predictive analytics platforms that use machine learning algorithms to identify high-risk patients and optimize treatment plans. 3) Multi-sensor implantable devices that offer enhanced diagnostic capabilities and patient monitoring, potentially improving outcomes through early intervention.

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Device

LINQ Sensor Algorithm for Heart Failure (ALLEVIATE-HF Trial)

N/A

Waitlist Available

Led By Javed Butler, MD

Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 has NYHA Class II or III heart failure per most recent assessment, irrespective of left ventricular ejection fraction (LVEF)

Must not have

Patient is on chronic intravenous inotropic drug therapy (e.g. dobutamine, milrinone).

Patient has had a heart transplant, or is currently on heart transplant list.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Summary

This trial tests a small device that monitors heart activity in patients with moderate heart failure. The device uses special software to help doctors manage patient care more effectively.

Who is the study for?

This trial is for adults over 18 with NYHA Class II or III heart failure who have had recent symptoms or treatments for heart failure. They must expect to live at least another year, be able to follow the study protocol, and not be part of another interventional study. People with severe kidney issues, low blood pressure, certain heart conditions, active cancer treatment, or those on mechanical circulatory support cannot join.

What is being tested?

The ALLEVIATE-HF study tests a new patient management approach using an algorithm from LINQ sensors to guide care in heart failure patients. It also assesses the safety of Reveal LINQ™ monitors and procedures. Participants are randomly assigned to either receive this new intervention or continue with standard care.

What are the potential side effects?

Potential side effects may include discomfort or complications from device insertion like infection or bleeding; however specific side effects related to the investigational RAMware download are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had heart failure symptoms or treatment recently.

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I have moderate heart failure according to my latest check-up.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on long-term IV medication to strengthen my heart.

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I have had a heart transplant or am on the waiting list for one.

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I am currently receiving chemotherapy or radiation for my cancer.

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I am not pregnant or breastfeeding, and I have a negative pregnancy test.

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My liver is not functioning properly, with high enzyme or bilirubin levels.

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I cannot tolerate a short-term increase in my water pill dosage.

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My kidney function is severely impaired.

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I have a heart condition like thickened heart muscle, stiff heart lining, or amyloid buildup.

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I am on long-term kidney dialysis.

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I have a severe narrowing of my heart valves.

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I have high blood pressure in the lungs not caused by heart disease.

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I have a complex heart condition that I was born with.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire and change in six-minute walk test distance

Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events

Secondary study objectives

Efficacy of patient management pathway - Hierarchical composite of Cardiovascular death, HF events, change in Kansas City Cardiomyopathy Questionnaire, change in six-minute walk test distance, and change in device-measured activity and night heart rate

Safety of Reveal LINQ™ system and procedure - Percentage of subjects experiencing system or procedure related serious adverse events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention ArmExperimental Treatment2 Interventions

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.

Group II: Observation ArmPlacebo Group1 Intervention

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.

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. ACE inhibitors work by relaxing blood vessels and reducing the workload on the heart. Beta-blockers slow the heart rate and decrease blood pressure, improving heart function. Diuretics help remove excess fluid from the body, reducing the strain on the heart. Aldosterone antagonists prevent fluid retention and reduce the risk of hospitalization. These treatments are crucial for heart failure patients as they help manage symptoms, improve quality of life, and reduce mortality. Diagnostic-based risk stratification, like the Reveal LINQ™ system, can further optimize patient care by tailoring treatments based on individual risk profiles, potentially leading to better outcomes.

Activation of immune and inflammatory systems in chronic heart failure: novel therapeutic approaches.