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Aortix Device for Heart Failure (DRAIN-HF Trial)
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
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 belowSelect...
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
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 moreTrial 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
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.
Find a Location
Who is running the clinical trial?
ProcyrionLead Sponsor
2 Previous Clinical Trials
41 Total Patients Enrolled
1 Trials studying Cardio-Renal Syndrome
21 Patients Enrolled for Cardio-Renal Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My urine output was less than 1500 ml in the last 12 hours despite taking high doses of water pills.I am over 21 years old and can sign a consent form.I still have swelling or fluid in my abdomen despite treatment with strong water pills.I am in the hospital for worsening heart failure, regardless of my heart's pumping strength.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Control Arm
- Group 3: Advanced HF Registry
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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