Doraya Catheter for Heart Failure

Recruiting at 17 trial locations

Overseen By Erin Mundstock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Revamp Medical Inc.

Must not be taking: High dose inotropes

Disqualifiers: Low blood pressure, Recent heart attack, Severe renal dysfunction, Advanced liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Doraya Catheter, for people with heart failure who aren't responding well to diuretics (medications that help remove excess fluid). Researchers aim to determine if this catheter can safely and effectively improve symptoms for those with acute heart failure, especially when fluid buildup is significant. Participants will receive either the usual diuretics or the Doraya Catheter along with diuretics. The trial seeks individuals hospitalized with acute heart failure and noticeable fluid retention, such as swollen legs or difficulty breathing while lying down. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participants should not have been treated with high-dose IV inotropes (medications that help the heart pump more effectively) within 2 days prior to enrollment.

What prior data suggests that the Doraya Catheter is safe for heart failure patients?

Research has shown that the Doraya catheter has been tested in patients with sudden heart failure, yielding promising results. Studies indicate that patients generally tolerate the catheter well. In one study involving nine patients, the Doraya catheter successfully reduced pressure in a major vein without causing significant side effects.

The catheter aims to lower pressure in the central veins, potentially improving kidney function in these patients. While the safety results are encouraging, it is important to note that this treatment remains under investigation in trials. More research is needed to fully understand its safety in larger populations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Doraya catheter for heart failure because it offers a unique approach compared to standard treatments like diuretics alone. Unlike traditional methods that mainly focus on reducing fluid buildup, the Doraya catheter is designed to modulate blood flow in the renal veins, potentially improving kidney function and overall heart performance. This innovative mechanism could enhance fluid management and provide relief more effectively, making it a promising option for those struggling with heart failure.

What evidence suggests that the Doraya Catheter is effective for heart failure?

Research has shown that the Doraya Catheter, which participants in this trial may receive, can help manage fluid buildup in patients with sudden heart failure. One study demonstrated that using the Doraya Catheter improved patient outcomes by altering the pressure in the inferior vena cava, a large vein. This change helps reduce congestion, a common issue for heart failure patients. The catheter shows particular promise for those who do not respond well to standard diuretics, offering a new way to manage their condition. This innovative method has shown early success in providing relief where other treatments have failed. ^{1 2 4 6 7}

Who Is on the Research Team?

Mike Favet

Principal Investigator

CEO

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am in the hospital because of acute heart failure.

IV diuretics do not work well for me.

You have signs of having too much fluid in your body.

Exclusion 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 have a serious heart condition like myocarditis or cardiomyopathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Doraya Catheter with diuretics or diuretics only

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Doraya catheter

Trial Overview 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.

How Is the Trial Designed?

Group I: Doraya Catheter Experimental Treatment 1 Intervention

Doraya Catheter with diuretics

Group II: Control Arm Active Control 1 Intervention

Diuretics only

Who Is Running the Clinical Trial?

Revamp Medical Inc.

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Percutaneous catheter valvuloplasty is an effective treatment for calcified aortic stenosis in elderly patients, achieving a primary success rate of 73% in a study of 37 patients aged 60-88 years.

The procedure can maintain functional improvements for up to 6 months in patients with moderate myocardial dysfunction, but those with severe dysfunction may experience recurrent heart failure and complications, indicating the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of percutaneous catheter valvuloplasty for calcified aortic stenosis in the elderly. Drobinski, G., Lechat, P., Metzger, JP., et al.[2019]

Valvuloplasty using a large-lumen balloon catheter effectively reduced the pressure gradient across the aortic valve in two patients with calcified aortic valve stenosis, leading to significant clinical improvement and resolution of cardiogenic shock symptoms.

The procedure was performed safely in both patients, with no significant increase in aortic insufficiency, suggesting that valvuloplasty can be a viable palliative treatment option for high-risk patients with aortic valve stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transfemoral valvuloplasty in calcified aortic valve stenosis]. Bussmann, WD., Reifart, N., Sievert, H., et al.[2006]

Invasive monitoring using the Swan-Ganz catheter can significantly improve patient management in cases of acute myocardial infarction by providing critical measurements such as cardiac pressures and output.

This catheter is particularly beneficial for patients experiencing severe left or right heart failure, complicated myocardial infarction, or severe hypovolemia, helping to guide treatment decisions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hemodynamics monitoring: correlations of clinical and invasive methods]. Bloch, A., Scheidegger, D.[2012]

Interventional heart failure therapies, including mechanical assist devices and heart transplantation, are crucial for treating end-stage refractory heart failure when drug therapies are insufficient.

Emerging treatments like cellular or stem cell therapy show promise for heart failure, alongside the importance of palliative care and self-care strategies in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation. Thompson, KA., Philip, KJ., Simsir, S., et al.[2010]

The Heartpod device developed by Savacor allows for real-time measurement of left atrial pressure in patients with congestive heart failure, enabling them to monitor their condition more effectively.

This innovative implantable device empowers patients to adjust their treatment based on precise intra-cardiac pressure data, potentially improving management of their heart failure symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Heartpod implantable heart failure therapy system. Walton, AS., Krum, H.[2022]

Device-based therapies, such as implantable defibrillators, are crucial for improving outcomes in heart failure patients, especially those who have experienced life-threatening arrhythmias like ventricular fibrillation.

Cardiac resynchronization therapy (CRT) shows promise in alleviating heart failure symptoms and is currently being evaluated in large trials (CARE-HF and COMPANION) for its impact on patient morbidity and mortality, highlighting the need for careful patient selection and trial integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome studies with device therapy in patients with heart failure. Cleland, JG., Thackray, S., Goodge, L., et al.[2019]

In a study involving three patients with severe pulmonic stenosis, balloon pulmonary valvuloplasty using the Inoue catheter significantly reduced right ventricular systolic pressure from 140 mmHg to 40 mmHg, indicating effective relief of obstruction.

The procedure also decreased the pulmonary valvular peak to peak systolic gradients from 120 mmHg to 8 mmHg, demonstrating that this technique is both feasible and safe for treating severe valvular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary valvuloplasty using Inoue balloon catheter. Bahl, VK., Chandra, S., Wasir, HS.[2019]

A new catheter designed for patients with severe aortic stenosis allows for high-pressure injections and maintains maneuverability, making it effective for catheterization in challenging cases.

In a study of 23 patients, the catheter successfully provided good-quality ventriculograms in 22 cases, demonstrating its efficacy and reliability for routine use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new catheter design for use in patients with critical aortic stenosis. Agarwal, JB., Klein, LW.[2019]

In a study of 56 patients with refractory congestive heart failure treated with chronic vasodilator therapy (hydralazine and nitrates), 73% reported subjective improvement and 59% showed improvement in heart function classifications within the first 6 months, with many sustaining these improvements over time.

Mortality rates were high, but significantly lower in patients who responded to treatment (21% in responders vs. 55% in nonresponders at 1 year), highlighting the importance of clinical response and specific hemodynamic indicators in predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term vasodilator therapy for heart failure: clinical response and its relationship to hemodynamic measurements. Massie, B., Ports, T., Chatterjee, K., et al.[2019]

In a study of 11,887 critically ill patients with cardiac disease, early pulmonary artery catheter placement did not improve 28-day mortality compared to those without the catheter, indicating no survival benefit from this intervention.

The use of pulmonary artery catheters was linked to fewer ventilation-free and vasopressor-free days in surgical patients, while nonsurgical patients experienced a higher risk of acute kidney injury, suggesting that the catheter's impact varies based on the patient's surgical status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early pulmonary artery catheterization is not associated with survival benefits in critically ill patients with cardiac disease: An analysis of the MIMIC-IV database. Wu, J., Liang, Q., Hu, H., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2452302X23000992

Safety, Feasibility of Controllable Decrease of Vena Cava ... In 9 acute heart failure patients, Doraya catheter deployment created a gradient in the inferior vena cava (below vs above the device), resulting in a ...

2. jacc.org jacc.org/doi/10.1016/j.jacbts.2022.02.013

Novel IVC Doraya Catheter Provides Congestion Relief in ... Novel IVC Doraya Catheter Provides Congestion Relief in Patients With Acute Heart Failure ... heart patient outcomes. Read More About JACC.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03234647

NCT03234647 | First In Human Study of the Doraya ... Submission of false or misleading clinical trial information; Failure to submit primary and secondary outcomes ... Doraya Catheter in Heart Failure. JACC Basic ...

4. withpower.com withpower.com/trial/phase-acute-decompensated-heart-failure-adhf-4-2022-d7f8b

Doraya Catheter for Heart Failure This trial is testing the Doraya Catheter, a device that helps manage fluid levels, in heart failure patients who do not respond well to typical treatments.

5. cordis.europa.eu cordis.europa.eu/project/id/855362/reporting

Doraya is an innovative catheter device for treating ... Doraya is an innovative catheter device for treating patients resistant to diuretics with Acute Heart Failure (AHF) condition. Reporting.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37138800/

Safety, Feasibility of Controllable Decrease of Vena Cava ... Lowering elevated central venous pressure may reduce renal dysfunction in acute heart failure (AHF) patients. The Doraya catheter lowers ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05206422

NCT05206422 | DORAYA-HF Early Feasibility Study There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...