← Back to Search

Device

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

N/A

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

ALLEVIATE-HF Trial Summary

This trial is testing a new way to manage heart failure that uses an algorithm to guide patient care. The goal is to show that this is safe and effective.

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.Check my eligibility

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.See study design

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.

ALLEVIATE-HF Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had heart failure symptoms or treatment recently.

Select...

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

Select...

I am 18 years old or older.

ALLEVIATE-HF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

ALLEVIATE-HF 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor

198 Previous Clinical Trials

128,030 Total Patients Enrolled

78 Trials studying Heart Failure

64,933 Patients Enrolled for Heart Failure

Javed Butler, MDPrincipal InvestigatorBaylor Scott and White Health

5 Previous Clinical Trials

4,037,957 Total Patients Enrolled

3 Trials studying Heart Failure

128,696 Patients Enrolled for Heart Failure

Media Library

Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04452149 — N/A

Heart Failure Research Study Groups: Observation Arm, Intervention Arm

Heart Failure Clinical Trial 2023: Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download Highlights & Side Effects. Trial Name: NCT04452149 — N/A

Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04452149 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many Canadian sites are administering this trial?

"This trial is presently taking place in 50 different sites located throughout the United States, such as Tupelo, Seattle and Albuquerque. To facilitate ease-of-access for participants it is recommended that they select a location nearest to them when enrolling."

Answered by AI

Is the recruitment process for this research project still ongoing?

"Evidenced by its listing on clinicaltrials.gov, this medical research initiative is actively seeking participants with the first posting having been made on September 3rd 2020 and a subsequent update taking place November 18th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

2020. "Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04452149.