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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is hospitalized with primary diagnosis of ADHF
Subject insufficiently responds to IV diuretic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours]
Awards & highlights
Study Summary
This trial is testing a new type of catheter to see if it is safe and effective for people with heart failure who haven't responded well to other treatments.
Who is the study for?
This trial is for hospitalized patients with acute decompensated heart failure (ADHF) who aren't responding well to IV diuretics. They must have fluid overload and high levels of certain heart-related biomarkers. It's not for those with very low blood pressure, recent heart attacks or interventions, complex congenital heart disease, severe valve disorders, active infections, or critical damage in multiple body systems.Check my eligibility
What is being tested?
The DORAYA-HF study is testing the Doraya Catheter's ability to manage fluid overload in ADHF patients who don't respond adequately to standard diuretic therapy. The goal is to assess how feasible and safe this catheter is when used in a real-world clinical setting.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include complications related to catheter insertion such as bleeding or infection at the site of entry, discomfort during the procedure, and any unforeseen reactions related to the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the hospital because of acute heart failure.
Select...
IV diuretics do not work well for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline [pre intervention] and accumulated through 24 hours [t=0-24 hours]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serious Adverse Events
Urine Output
Trial Design
1Treatment groups
Experimental Treatment
Group I: ADHF patientsExperimental Treatment1 Intervention
ADHF patients with insufficient response to diuretics treated with the Doraya catheter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doraya catheter
2018
N/A
~10
Find a Location
Who is running the clinical trial?
Revamp Medical Inc.Lead Sponsor
Yael ShohatStudy DirectorCEO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is too low (less than 90 mmHg) when checked at the screening.I have a severe heart valve problem or need surgery for it.I am in the hospital because of acute heart failure.I have a serious heart condition like myocarditis or cardiomyopathy.I haven't had a heart attack, severe heart condition, or any heart-related procedures in the last 14 days.You are in very bad health and have severe damage in more than 3 important parts of your body, according to the doctor's opinion.IV diuretics do not work well for me.I have a complex heart condition from birth.You have signs of having too much fluid in your body.I have an ongoing infection with a fever over 100°F or it's not improving with antibiotics.Your N-terminal-pro-brain natriuretic peptide (NT-proBNP) is greater than or equal to 1,000 pg/m or your BNP is greater than or equal to 250 pg/mL.
Research Study Groups:
This trial has the following groups:- Group 1: ADHF patients
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 individuals over the age of 35 eligible to participate in this scientific experiment?
"As per the requirements, only those aged 18 and over but below 85 are eligible to take part in this medical experiment."
Answered by AI
What is the aggregate size of this medical experiment's cohort?
"Affirmative. Clinicaltrials.gov attests to this medical trial being open for recruitment, which began on May 23rd 2022 and has been refreshed as recently as July 10th 2022. There is a need to identify 15 participants from 5 different sites."
Answered by AI
Is this research endeavor actively accepting participants?
"Affirmative. According to the materials on clinicaltrials.gov, this medical trial posted in May of 2022 is actively recruiting participants. All together, 15 people need to be enrolled from 5 distinct sites."
Answered by AI
Which demographics are most advantageous for this clinical trial?
"Applicants aged 18 to 85 suffering from acute decompensated heart failure (ADHF) are welcome to join this medical trial. Candidates must also meet the following prerequisites: a hospitalisation with ADFH as primary diagnosis, NT-proBNP or BNP levels of at least 1600 pg/m and 400pg/mL respectively, clear signs of fluid overload, and an insufficient reaction to IV diuretics."
Answered by AI
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