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NCT04149743 · Aventusoft, LLC.

HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

(HATS-OFF)

What this study is about

Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.

View original scientific description

Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Age greater than or equal to 22 years old.
  • An index hospital admission for ADHF presenting with symptoms, clinical signs, and chest x-ray (CXR) findings of pulmonary congestion, receiving IV diuretics or vasoactive drugs and having a BNP \> 350 or NT-pro BNP \> 1800 pg/ml.
  • Able to give informed consent.
  • Participant's residence has adequate cellular data coverage.
  • Participants with previous diagnosis of left ventricular ejection fraction (LVEF) \<40% prior to the index hospitalization must have been treated for at least 90 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contraindicated) and an ACE inhibitor or ARB or ARNi (unless intolerant or contraindicated).

Exclusion criteria

  • Participants unable to provide informed, voluntary decision to participate in research study as determined by the investigator. (Exclude participants who necessitate the involvement of a legally authorized representative.)
  • Terminal condition with life expectancy less than 6 months as determined by investigator.
  • Participants with cardiac tamponade or constrictive pericarditis.
  • Participants with left ventricular assistance device (LVAD device) or had a cardiac transplantation or listed for transplantation.
  • Implantation of a CRT (cardiac resynchronization therapy) device during index hospitalization or intent to implant a CRT device.
  • Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation, as determined by investigator.
  • Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis, as determined by investigator.
  • Severe primary pulmonary, renal or hepatic disease, as determined by investigator.
  • Women of childbearing age (Age \<50).
  • History of pulmonary embolism of less than 3 months.
  • Dialysis dependent or dialysis initiation expected within three months.
  • Chronic home IV therapy or cardiac inotropes or diuretics.
  • Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.
  • Illness/ Condition which may be aggravated or cause significant discomfort by the application of the HEMOTAG (skin issues, e.g. Intolerance to use of skin electrodes).
  • Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.
  • Congenital heart malformations (Complex, or uncorrected congenital heart disease).
  • Participant enrolled in another interventional study (observational or registries are not excluded).
  • Participant HF is managed remotely with another monitoring device or program (for example: Pulmonary/ Lt Atrial pressure monitoring, lung fluid monitoring. BNP/pro-BNP or bioimpedance or ICD or biventricular pacemaker with impedance monitoring will be allowed unless it is part of another research protocol).
  • Prisoners and wards of the state.
  • Inability to provide informed consent (Must speak English or Spanish or Creole).

Where

  • Weston, Florida
  • Temple, Texas

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Aug 21, 2024 · Source of record for eligibility and locations

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1 of 420 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Weston

Florida

Location available
RECRUITING

Temple

Texas

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Heart Failure Trials by City

Browse all heart failure clinical trials in these cities — not just this study.

Looking for Heart Failure (HF) Treatment in Weston?

Join others in Florida exploring innovative treatment options through clinical research

Heart Failure (HF) Treatment Options in Weston, Florida

If you're searching for Heart Failure (HF) treatment in Weston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Weston, Temple and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Heart Failure (HF). All study-related care is provided at no cost to participants.

Local Sites
2 locations in Florida
Now Enrolling
Up to 420 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Heart Failure (HF)?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Heart Failure (HF)

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Heart Failure (HF) Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04149743. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.