← Back to Search

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 must be 18 years old or older

Must not have

Skin damage or significant arthritis, preventing wearing of device

Uncontrolled seizures or other neurological disorders leading to excessive abnormal movements or tremors in the upper body

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

My heart condition limits my physical activity.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I cannot wear devices due to skin damage or severe arthritis.

Select...

I have seizures or neurological issues causing abnormal movements or tremors.

Select...

I am expected to get a heart pump or heart transplant within the next month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

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

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

Primary study objectives

Heart failure hospitalization rate

Secondary study objectives

Kansas City Cardiomyopathy Questionaire Score

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.

0 / 5Eligibility criteria met