Not Yet RecruitingNot Applicable

Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance

Australia, Georgia5 participantsStarted 2024-08

Plain-language summary

Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. Admitted to the hospital with a primary diagnosis of ADHF
. Clinical signs and/or symptoms of congestion defined as at least one of the following: dyspnea at rest or with minimal exertion, orthopnea, lower extremity edema (≥2+), elevated jugular venous pressure, pulmonary rales, pulmonary vascular congestion on chest x-ray, pleural effusion or ascites
. Projected need by the treating clinician for continued treatment with IV diuretic agents for more than 48 hours with the goal of significant fluid removal (more than 1L net fluid loss/24h)
. Appropriate intravenous loop diuretic therapy at the time of enrollment, defined as at least the higher of:
. Furosemide 40mg IV bid or equivalent
. IV furosemide or equivalent IV loop diuretic equivalent to ≥2x the total oral daily loop diuretic dose at home in 2 divided doses
. Diuretic resistance defined as at least ONE of the following:
. Urine output of less than 1.5L over 12h following the last diuretic dose, OR

Exclusion criteria

. ADHF related to acute secondary disease (i.e., infection or acute coronary syndrome)

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

Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)

Timeframe: Baseline to 30-day Follow-Up

Technical success defined as successful device deployment, ability to deliver the treatment and remove the device

Timeframe: Baseline to 30-day Follow-Up

Assisted decongestion success defined as increase in the average hourly rate of urine output during the first 24 hours of ModulHeart-assisted decongestive therapy compared to the last 24 hours of diuretic therapy prior to pump implant

Timeframe: Baseline to 1 day of ModulHeart-assisted decongestive therapy

Trial details

NCT IDNCT06174623

SponsorPuzzle Medical Devices Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Gabriel Georges

514-758-8971 gabriel.georges@puzzlemed.com

View on ClinicalTrials.gov More Heart Failure trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. Admitted to the hospital with a primary diagnosis of ADHF
. Clinical signs and/or symptoms of congestion defined as at least one of the following: dyspnea at rest or with minimal exertion, orthopnea, lower extremity edema (≥2+), elevated jugular venous pressure, pulmonary rales, pulmonary vascular congestion on chest x-ray, pleural effusion or ascites
. Projected need by the treating clinician for continued treatment with IV diuretic agents for more than 48 hours with the goal of significant fluid removal (more than 1L net fluid loss/24h)
. Appropriate intravenous loop diuretic therapy at the time of enrollment, defined as at least the higher of:
. Furosemide 40mg IV bid or equivalent
. IV furosemide or equivalent IV loop diuretic equivalent to ≥2x the total oral daily loop diuretic dose at home in 2 divided doses
. Diuretic resistance defined as at least ONE of the following:
. Urine output of less than 1.5L over 12h following the last diuretic dose, OR

Exclusion criteria

. ADHF related to acute secondary disease (i.e., infection or acute coronary syndrome)

What they're measuring

Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)

Timeframe: Baseline to 30-day Follow-Up

Technical success defined as successful device deployment, ability to deliver the treatment and remove the device

Timeframe: Baseline to 30-day Follow-Up

Timeframe: Baseline to 1 day of ModulHeart-assisted decongestive therapy