Evaluating the Doraya Catheter for heart failure patients

DORAYA-HF: 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 aren't getting better with regular medications by managing their fluid overload.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Revamp Medical Ltd. (industry)
• Locations: 11 sites (San Francisco, California and 10 other locations)
• Trial ID: NCT05206422 on ClinicalTrials.gov

What this trial studies

This study aims to assess 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. Participants will be monitored for safety and effectiveness as the catheter is used to manage fluid overload. The study focuses on patients exhibiting specific clinical signs of fluid retention and insufficient diuretic response. By measuring various clinical endpoints, the study seeks to determine the potential benefits of this new intervention.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults over 18 years old diagnosed with acute decompensated heart failure and exhibiting signs of fluid overload.

Not a fit: Patients who do not have acute decompensated heart failure or those who respond adequately to diuretic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with acute decompensated heart failure who struggle with fluid overload.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in managing fluid overload in heart failure patients, suggesting potential for success.

Eligibility criteria

INCLUSION.

1. Subject is \>18 years of age.
2. Subject is hospitalized with primary diagnosis of ADHF.
3. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.
4. Evidence of fluid overload as indicated by 2 or more of the following criteria:

   1. peripheral edema ≥ 2+
   2. radiographic pulmonary edema or pleural effusion
   3. enlarged liver or ascites
   4. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
   5. Jugular venous distention \> 7 cmH2O
5. IVCCI \< 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).
6. Subject insufficiently responds to IV diuretic therapy defined as average hourly urine output \<125ml/hour over 6 hours OR cumulative urine output \< 3L over 24 hours OR a Net Fluid Loss \<375mL in a 12-hour timeframe following ≥2 diuretic challenges with a minimum of:

   1. 1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or equivalent.
   2. 2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.
7. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study. Females of child-bearing potential must have a negative pregnancy test.

   Procedural Inclusion Criterion
8. CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral line, pigtail, Swan Ganz, or other indwelling catheter.

EXCLUSION

1. Systolic blood pressure \<90 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. Known LVEF \< 10% by echocardiography within 1 year prior to enrollment.
4. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
5. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
6. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
7. Subject has severe renal dysfunction, defined as either eGFR \<25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
8. Subject with advanced liver disease: either Total Bilirubin \> 4 mg/dL or Serum sodium (corrected for glucose) \< 125 mmol/L.
9. Treatment with high dose IV inotropes within 2 days prior to enrollment. High dose is defined as \> 1 unit of inotrope (excluding Digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit.
10. Subject with a history of:

    1. Deep vein thrombosis that occurred \< 6 months prior to enrollment, and/or;
    2. Pulmonary embolism episode that occurred \< 6 months prior to enrollment.
11. 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 hrs of antibiotic treatment).
12. Subjects with a known infra-renal IVC diameter of \<16mm.
13. 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

San Francisco, California and 10 other locations

• Zuckerberg San Francisco General — San Francisco, California, United States (RECRUITING)
• San Francisco VA — San Francisco, California, United States (RECRUITING)
• UCSF — San Francisco, California, United States (RECRUITING)
• Cleveland Clinic — Weston, Florida, United States (RECRUITING)
• Henry Ford — Detroit, Michigan, United States (WITHDRAWN)
• Christian Hospital — Saint Louis, Missouri, United States (TERMINATED)
• UMC of Southern Nevada — Las Vegas, Nevada, United States (RECRUITING)
• The Christ Hospital — Cincinnati, Ohio, United States (RECRUITING)
• The MetroHealth System — Cleveland, Ohio, United States (RECRUITING)
• The Ohio State University — Columbus, Ohio, United States (RECRUITING)
• Oklahoma Heart — Oklahoma City, Oklahoma, United States (RECRUITING)

Study contacts

• Study coordinator: Judit Adorjan

Conditions: Acute Decompensated Heart Failure, ADHF