Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diure… (NCT06174623) | Clinical Trial Compass
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 range21 Years
SexALL
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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
✓. 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)
✕. Treatment with high dose inotropes (milrinone ≥0.375 mcg/kg/min, dobutamine ≥5mcg/kg/min or dopamine ≥5mcg/kg/min) and/or treatment with vasopressors to maintain a systolic arterial blood pressure ≥90 mmHg or mean arterial blood pressure ≥60 mmHg
What they're measuring
1
Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)
Timeframe: Baseline to 30-day Follow-Up
2
Technical success defined as successful device deployment, ability to deliver the treatment and remove the device
Timeframe: Baseline to 30-day Follow-Up
3
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
. Current or previous support with a durable left ventricular assist device (LVAD) at any time or use of an extracorporeal membrane oxygenation (ECMO), percutaneous ventricular assist devices, intra-aortic balloon pump or patient on home inotropes currently or within the last 30 days
✕. Recent myocardial infarction, percutaneous coronary intervention or surgical revascularization (within the last 30 days) or awaiting planned coronary intervention or surgery
✕. Fixed pulmonary vascular resistance of more than 5 Wood units, estimated PASP of more than 80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure
✕. Prior heart transplant, heart failure due to rejection of a previous heart transplant, or planned heart transplantation
✕. Reanimated cardiac arrest in the last 30 days
✕. Suspected or known amyloid disease or other restrictive cardiomyopathy