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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
DRAIN-HF Trial Summary
This trial tests a device to help chronic heart failure patients who don't respond to medicine.
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.Check my eligibility
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.See study design
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.
DRAIN-HF Trial 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.
DRAIN-HF Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
All-cause Mortality
HF Re-Hospitalization or escalation of HF therapy
Incidence and percentages of major adverse events (MAE) Pooled
+5 moreDRAIN-HF 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
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings for individuals to partake in this experiment?
"According to current information on clinicaltrials.gov, this experiment is actively enrolling patients. Initially posted on August 23rd 2023 and most recently amended the same day, participants are being sought for this research initiative."
Answered by AI
How many individuals are eligible to participate in this clinical experiment?
"Affirmative. Clinicaltrials.gov provides evidence that the trial, which was announced on August 23rd 2023, is searching for participants to join. The exact number of people needed at this one site is 268 individuals."
Answered by AI
What is the aim of this clinical experiment?
"According to Procyrion, the sponsor of this study, their main objective will be measured over a Baseline-to-30 day Follow Up period. This primary endpoint is comprised of reductions in net fluid loss and freedom from mortality or heart failure rehospitalization/therapy escalation when compared with baseline assessment. Furthermore, secondary measurements such as NT-proBNP levels, Net Fluid Loss fluctuations between Days 0 and 7 (or discharge), and All Cause Mortality rate are also being monitored during the course of this research venture."
Answered by AI
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