Using the Doraya Catheter to treat heart failure patients not responding to diuretics

DORAYA-HF EU: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics

This study is testing a new catheter to see if it can help heart failure patients who haven't improved with regular medications by better managing their fluid buildup.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Revamp Medical Ltd. (Industry-sponsored)
• Locations: 7 sites (Tbilisi and 6 other locations)
• Trial ID: NCT05876078 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility and clinical performance of the Doraya Catheter in patients hospitalized with acute decompensated heart failure (ADHF) who have not responded adequately to diuretic therapy. The trial focuses on measuring safety endpoints and the effectiveness of the catheter in managing fluid overload in these patients. Participants must meet specific criteria, including elevated levels of NT-proBNP and evidence of fluid overload, to be eligible for the intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized patients diagnosed with acute decompensated heart failure who show insufficient response to intravenous diuretics.

Not a fit: Patients with severe cardiovascular conditions or those who have recently undergone significant cardiac interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with ADHF who do not respond to standard diuretic therapy.

How similar studies have performed: While the use of catheters in heart failure management is not novel, the specific application of the Doraya Catheter in this context is relatively untested.

Eligibility criteria

Inclusion Criteria:

1. Subject is hospitalized with primary diagnosis of ADHF.
2. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m orvBNP≥250 pg/mL.
3. Evidence of fluid overload.
4. Subject insufficiently responds to IV diuretic therapy

Exclusion Criteria:

Systolic blood pressure \< 80 mmHg at the time of screening. 2. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days. 3. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).

4. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.

5. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.

6. Evidence of active systemic infection documented by either one of the following: fever \>38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite \> 48 hours of antibiotic treatment).

7. Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.

Where this trial is running

Tbilisi and 6 other locations

• LLC Bokhua Memorial Cardiovascular Center — Tbilisi, Georgia (Withdrawn)
• LTD Israel Georgian Medical Research Clinic Helsicore — Tbilisi, Georgia (Withdrawn)
• Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego Państwowy Instytut Badawczy — Warsaw, Poland (Recruiting)
• Mikulicz-Radecki University Teaching Hospital in Wrocław — Wrocław, Poland (Recruiting)
• Suscch — Banská Bystrica, Slovakia (Recruiting)
• CINRE, s.r.o. — Bratislava, Slovakia (Recruiting)
• Hospital clinic de Barcelona — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Sahar Boostenay

Conditions Acute Decompensated Heart Failure; ADHF