What side effects are associated with this type of intervention?

Common treatments for heart failure that involve decongestive therapy, such as diuretics, aim to remove excess fluid from the body. The known side effects of these treatments include electrolyte imbalances (such as low potassium or sodium levels), dehydration, kidney dysfunction, and hypotension (low blood pressure). Additionally, patients may experience dizziness, increased urination, and, in some cases, worsening renal function. It is important to monitor these side effects closely to manage and adjust treatment as necessary.

What prior FDA approvals exist?

FDA-approved treatments for heart failure that focus on decongestive therapy by removing excess fluid include diuretics such as furosemide, torsemide, and bumetanide. These medications help reduce fluid buildup in the body, alleviating symptoms of heart failure. Additionally, aldosterone antagonists like spironolactone and eplerenone, as well as vasodilators such as hydralazine and isosorbide dinitrate, are used to manage heart failure symptoms and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to the Reprieve DMS system for heart failure patients include: 1) SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) which have shown benefits in reducing heart failure hospitalizations and improving cardiovascular outcomes. 2) Vericiguat, a soluble guanylate cyclase stimulator, which has been shown to reduce the risk of heart failure hospitalization and cardiovascular death. 3) CardioMEMS HF System, an implantable pulmonary artery pressure monitoring device that helps in managing heart failure by allowing for proactive adjustments in therapy. 4) Sacubitril/valsartan (Entresto), an angiotensin receptor-neprilysin inhibitor, which has demonstrated significant improvements in heart failure outcomes.

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Diuretic

Fluid Management Systems for Heart Failure (FASTR Trial)

N/A

Recruiting

Research Sponsored by Reprieve Cardiovascular, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign

Prior use of loop diuretics within 30 days prior to admission

Must not have

Inability of the patient to stand and obtain daily standing weights

Dyspnea due primarily to non-cardiac causes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the Reprieve DMS system, a device that removes excess fluid, to usual treatment in patients with acute decompensated heart failure. The goal is to see if the device can more effectively reduce fluid buildup and improve symptoms. Newer devices make it feasible in most hospitals.

Who is the study for?

This trial is for hospitalized patients with acute decompensated heart failure who have symptoms and signs of the condition, are significantly above their dry weight, and have been on loop diuretics. It's not suitable for those with unstable vital signs, non-heart-related breathing issues, severe infections or electrolyte problems, active COVID-19, other serious health conditions including substance abuse or mental disorders that affect study compliance.

What is being tested?

The study compares a new therapy using the Reprieve Decongestion Management System to standard Optimal Diuretic Therapy in treating acute decompensated heart failure. The goal is to see if the Reprieve system can better remove excess fluid from patients compared to conventional diuretic treatment.

What are the potential side effects?

While specific side effects aren't listed here, treatments like these may cause changes in blood pressure, kidney function alterations, electrolyte imbalances (like low potassium), discomfort at catheter sites and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am hospitalized with heart failure, having both symptoms and signs.

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I have used water pills within the last 30 days.

Exclusion Criteria

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

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I cannot stand up to weigh myself daily.

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My shortness of breath is mainly not because of heart issues.

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My blood pressure and heart rate are stable.

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I am pregnant or planning to become pregnant.

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I currently have an active COVID-19 infection.

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I cannot have a Foley or IV catheter placed.

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I currently have an infection that is affecting my whole body.

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I cannot come back for follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 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

Clinically significant acute kidney injury, severe electrolyte abnormality, symptomatic hypotension or hypertensive emergency.

Total urine sodium output

Secondary study objectives

Net fluid loss

Time on loop diuretics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Reprieve Decongestion Management SystemExperimental Treatment1 Intervention

Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.

Group II: Optimal Diuretic TherapyActive Control1 Intervention

Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Heart Failure (HF) treatments primarily aim to reduce symptoms, improve quality of life, and decrease mortality. Diuretics, such as furosemide, help remove excess fluid from the body, reducing the workload on the heart and alleviating symptoms like edema and shortness of breath. ACE inhibitors and beta-blockers improve heart function by reducing blood pressure and heart rate, thus decreasing the heart's workload. The Reprieve DMS system, a decongestive therapy, specifically targets fluid overload by efficiently removing excess fluid, which is crucial for patients with acute decompensated heart failure. This approach helps to rapidly relieve symptoms and prevent further complications, highlighting the importance of effective fluid management in HF treatment.