DORAYA-HF Early Feasibility Study (NCT05206422) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
DORAYA-HF Early Feasibility Study
United States30 participantsStarted 2022-10-05
Plain-language summary
The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is \>18 years of age.
. Subject is hospitalized with primary diagnosis of ADHF.
. N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.
. Evidence of fluid overload as indicated by 2 or more of the following criteria:
. peripheral edema ≥ 2+
. radiographic pulmonary edema or pleural effusion
. enlarged liver or ascites
. pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
Exclusion criteria
. Systolic blood pressure \<90 mmHg at the time of screening.
. Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
. Known LVEF \< 10% by echocardiography within 1 year prior to enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serious Adverse Events
Timeframe: 30 days
2
Urine Output
Timeframe: baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]
. Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
. Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
. Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
. Subject has severe renal dysfunction, defined as either eGFR \<25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
. Subject with advanced liver disease: either Total Bilirubin \> 4 mg/dL or Serum sodium (corrected for glucose) \< 125 mmol/L.