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Remote Heart Failure Monitoring for Heart Failure (LINK-HF2 Trial)

N/A
Recruiting
Led By Josef Stehlik, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA( New York Heart Association Functional Classification) Class II-IV, documented in site's medical record system
Subject willing and able to perform all study related procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

LINK-HF2 Trial Summary

This trial will test whether a remote monitoring system can be used to detect worsening heart failure before the patient needs medical care, in order to change their treatment and avoid a hospitalization.

Who is the study for?
This trial is for Veterans aged 18 or older with heart failure classified as NYHA Class II-IV. Participants must be able to give informed consent and perform study procedures. It's not for pregnant/nursing women, those with visual/cognitive impairments that prevent protocol adherence, imminent heart surgery patients, individuals with skin damage/arthritis affecting device wearability, or uncontrolled seizures/neurological disorders.Check my eligibility
What is being tested?
The LINK-HF2 trial tests if remote monitoring using a wearable sensor and predictive analytics can detect worsening heart failure early enough to adjust treatment and avoid hospitalization. Of the 240 participants, half will be randomly chosen to have their data monitored and shared with medical teams to guide care.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring rather than medication or invasive procedures, traditional side effects are minimal. However, there may be discomfort from wearing the device or privacy concerns related to remote health data transmission.

LINK-HF2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart condition limits my physical activity.
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I am willing and able to follow all study requirements.
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I am 18 years old or older.

LINK-HF2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart failure hospitalization rate
Secondary outcome measures
Kansas City Cardiomyopathy Questionaire Score

LINK-HF2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active armExperimental Treatment1 Intervention
Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.
Group II: ControlPlacebo Group1 Intervention
Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,607 Previous Clinical Trials
3,305,795 Total Patients Enrolled
38 Trials studying Heart Failure
62,948 Patients Enrolled for Heart Failure
George E. Wahlen Department of Veterans Affairs Medical CenterUNKNOWN
Michael E. DeBakey VA Medical CenterFED
64 Previous Clinical Trials
15,548 Total Patients Enrolled
2 Trials studying Heart Failure
205 Patients Enrolled for Heart Failure

Media Library

Remote monitoring and predictive analytics Clinical Trial Eligibility Overview. Trial Name: NCT04502563 — N/A
Heart Failure Research Study Groups: Control, Active arm
Heart Failure Clinical Trial 2023: Remote monitoring and predictive analytics Highlights & Side Effects. Trial Name: NCT04502563 — N/A
Remote monitoring and predictive analytics 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502563 — N/A

Frequently Asked Questions

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

Are there still slots available for participants in this trial?

"According to clinicaltrials.gov, this experiment is currently in a recruiting state and has been since April 19th 2021. The relevant information was last updated on March 23rd 2022."

Answered by AI

What is the scope of participation for this research project?

"Affirmative. According to clinicaltrials.gov, this research is currently in search of participants, with the first post dating back to April 19th 2021 and most recent amendment on March 23rd 2022. 240 patients are sought after from 5 specified medical sites."

Answered by AI

Are there numerous venues in the United States conducting this research?

"This research project is occurring at 5 different locations, such as the Michael E. DeBakey VA Medical Center in Houston, TX; the VA Palo Alto Health Care System in Palo Alto, CA; and the VA Salt Lake City Health Care System in SaltLakeCity, UT. Additionally, there are two other sites participating."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Michael E. DeBakey VA Medical Center, Houston, TX
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

~40 spots leftby Oct 2024