What side effects are associated with this type of intervention?

Common treatments for Cardio-Renal Syndrome, particularly those involving circulatory support devices like the Aortix, can have several side effects. Diuretics may cause electrolyte imbalances, dehydration, and kidney dysfunction. ACE inhibitors can lead to hypotension, hyperkalemia, and renal impairment. Beta-blockers might cause bradycardia, fatigue, and worsening heart failure in some cases. Circulatory support devices, while beneficial, can be associated with risks such as infection, bleeding, thrombosis, and device malfunction. It is essential to monitor patients closely to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Cardio-Renal Syndrome, particularly focusing on heart failure management and circulatory support. Notable approvals include left ventricular assist devices (LVADs) like the HeartMate series, which provide mechanical circulatory support for patients with severe heart failure. Additionally, pharmacologic treatments such as diuretics, ACE inhibitors, and beta-blockers are commonly used to manage symptoms and improve heart function. The Aortix device, currently under study, aims to offer a novel approach by providing endovascular circulatory support specifically for patients with acute decompensated heart failure and diuretic resistance.

What other types of research exist?

Promising alternatives to the Aortix device for Cardio-Renal Syndrome patients include the following: 1) The Impella device, which provides percutaneous ventricular assist to support cardiac output. 2) The CardioMEMS HF System, an implantable pulmonary artery pressure monitoring device that helps manage heart failure. 3) The BAROSTIM NEO System, a neuromodulation device that improves heart function by stimulating the baroreceptors. These alternatives have shown potential in improving outcomes for patients with heart failure and related conditions.

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Not applicable

Aortix Device for Heart Failure (DRAIN-HF Trial)

Q: What is the mechanism of action of this treatment?

Cardio-Renal Syndrome (CRS) involves the interplay between heart and kidney dysfunction, where the failure of one organ can lead to the failure of the other. Common treatments for CRS include diuretics, which help reduce fluid overload by increasing urine production, and inotropes, which improve heart contractility to enhance cardiac output. Vasodilators are also used to reduce the workload on the heart by dilating blood vessels. The Aortix device, a circulatory support device, works by augmenting blood flow and reducing cardiac workload, which can be particularly beneficial for patients with acute decompensated heart failure resistant to diuretic therapy. These treatments are crucial for CRS patients as they help manage fluid balance, improve cardiac function, and ultimately enhance renal perfusion, thereby breaking the vicious cycle of heart and kidney failure.

N/A

Recruiting

Research Sponsored by Procyrion

Eligibility Criteria Checklist

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

Must have

Urine output for 12 hours prior to enrollment is < 1500 ml following at least 48 hours of the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated;

Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema or ascites after treatment with IV diuretics per inclusion criterion 2.;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 30 day follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device called Aortix that helps the heart pump blood better. It targets patients with severe heart failure who don't get better with usual treatments. The device works by helping the heart move blood more efficiently.

Who is the study for?

This trial is for hospital-admitted adults over 21 with acute decompensated heart failure who haven't responded well to at least 48 hours of high-dose diuretics. They should have symptoms like swelling or fluid buildup despite treatment, and women must not be pregnant.

What is being tested?

The study compares the Aortix circulatory support device against standard medical management in patients with chronic heart failure hospitalized for acute episodes and resistant to diuretic therapy. Participants are randomly assigned to one of these two approaches.

What are the potential side effects?

While specific side effects aren't listed here, devices like Aortix may cause complications such as bleeding, infection at the insertion site, blood clots, or issues related to heart function.

Eligibility Criteria

Inclusion Criteria

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

Select...

My urine output was less than 1500 ml in the last 12 hours despite taking high doses of water pills.

Select...

I still have swelling or fluid in my abdomen despite treatment with strong water pills.

Select...

I am in the hospital for worsening heart failure, regardless of my heart's pumping strength.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 30 day follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 30 day follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 30 day follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint: Combined composite of clinically significant reduction in net fluid loss over 7 days and freedom from mortality or heart failure re-hospitalization/therapy escalation from the baseline visit to the 30-day follow-up visit.

Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.

Secondary study objectives

All-cause Mortality

HF Re-Hospitalization or escalation of HF therapy

Incidence and percentages of major adverse events (MAE) Pooled

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management. Randomization will be stratified by ejection fraction.

Group II: Advanced HF RegistryExperimental Treatment1 Intervention

For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.

Group III: Control ArmActive Control1 Intervention

The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aortix System

2021

N/A

~30

0 / 3Eligibility 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

Cardio-Renal Syndrome (CRS) involves the interplay between heart and kidney dysfunction, where the failure of one organ can lead to the failure of the other. Common treatments for CRS include diuretics, which help reduce fluid overload by increasing urine production, and inotropes, which improve heart contractility to enhance cardiac output. Vasodilators are also used to reduce the workload on the heart by dilating blood vessels. The Aortix device, a circulatory support device, works by augmenting blood flow and reducing cardiac workload, which can be particularly beneficial for patients with acute decompensated heart failure resistant to diuretic therapy. These treatments are crucial for CRS patients as they help manage fluid balance, improve cardiac function, and ultimately enhance renal perfusion, thereby breaking the vicious cycle of heart and kidney failure.