TerminatedNot Applicable

Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters

Stopped: enrollment futility

United States40 participantsStarted 2011-05

Plain-language summary

The purpose of the Heart Failure and Risk of re-Admissions Determined by Abnormal REVEAL Parameters (HF RADAR) study is to evaluate the ability of cardiac rhythm (Cardiac Compass) data to predict future cardiac events in heart failure (HF) patients recently discharged after a hospitalization for heart failure who have or plan to have a implanted loop recorder (ILR), specifically, the Reveal XT device. The study will enroll 40 HF patients (with LV function ≥ 40%) admitted to an acute care facility (observation status or hospital stay) for heart failure who either have a Reveal XT device in place or plan to have the ILR device inserted for clinical indication within 14 days of discharge from the hospitalization. HF patients will be followed for 6 months. Device date will be captured during normal clinic visits and at 6 months.

Who can participate

Age range

18 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and non-pregnant/non lactating women ≥ 18 years.
. Admission to hospital or observation unit for worsening heart failure.
. Has a Reveal XT device or has plans for a device implant for a clinical indication within 14 days of discharge.
. Ejection fraction ≥40% by echocardiogram within 6 months of enrollment
. Able to participate in the study for at least 6 months.
. Not currently enrolled in another study.
. Able to provide informed consent and complete scheduled study visits.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Worsening HF symptoms or HF-related clinical events

Timeframe: 6 months

Trial details

NCT IDNCT01357408

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Heart Failure trials