Pentoxifylline for Heart Failure

Overseen By Dominic Emerson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Methylxanthines

Disqualifiers: ECMO, RVAD, Heparin intolerance, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: Up to 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Pentoxifylline can reduce complications in people with severe heart failure who require a temporary heart support device called the Impella. The Impella device can sometimes damage red blood cells, leading to further health issues. Pentoxifylline might protect these cells and reduce blood damage. Participants will receive either this medication or a placebo to assess its effects. This trial suits those with heart failure who have had an Impella device inserted into their axillary artery, a major artery in the shoulder. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Pentoxifylline?

Research has shown that pentoxifylline is generally safe and well-tolerated in people with heart conditions. Studies with heart failure patients have found that pentoxifylline can significantly lower death rates. One study revealed nearly four times fewer deaths among those treated with pentoxifylline compared to those who were not.

Other research indicates that patients with heart conditions experienced improvements in heart function without major side effects. Another study found that using pentoxifylline for two months in patients with heart issues was safe, with no significant negative effects reported.

Overall, the evidence suggests that pentoxifylline is safe for heart patients, making it a promising option for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Pentoxifylline is unique because it offers a novel approach to managing heart failure. Unlike standard treatments that primarily focus on improving heart muscle function and fluid balance, pentoxifylline works by enhancing blood flow and reducing inflammation. This distinct mechanism of action might provide benefits for patients who need additional ways to manage their symptoms. Researchers are excited about its potential to complement existing therapies and offer a new avenue for improving heart health.

What evidence suggests that pentoxifylline might be an effective treatment for heart failure?

Research has shown that pentoxifylline, which participants in this trial may receive, can improve symptoms in people with heart failure. Some studies have found that it enhances heart function and may even lower the risk of death. Pentoxifylline works by increasing the flexibility of red blood cells, allowing them to move more easily through blood vessels. This can reduce stress on the blood cells, potentially lowering the risk of damage and clotting. While further research is needed to fully understand pentoxifylline's effects on heart failure, these findings suggest it might aid in improving blood flow and heart health. ^{2 3 6 7 8}

Who Is on the Research Team?

Domininc Emerson, MD

Principal Investigator

Cedars-Sinai Medical Center; Smidt Heart Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who are getting an Impella device inserted due to acute decompensated heart failure. It's not for those who've had recent brain or eye bleeding, pregnant or nursing women, people allergic to Pentoxifylline or similar stimulants, have a specific blood platelet condition (HIT), or are on other mechanical circulatory support.

Inclusion Criteria

I have heart failure and had an Impella device inserted for worsening symptoms.

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant.

Concomitant temporary mechanical circulatory support (ECMO, RVAD)

I have had a recent brain or eye bleed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either Pentoxifylline or placebo every 6 hours from device implant until device explant, death, or Day 30

Up to 30 days

Continuous monitoring with lab tests every 12 hours for the first 3 days, then daily

Follow-up

Participants are monitored for safety and effectiveness after treatment, including device malfunction, bleeding, and infection

Up to 30 days post-device implant

What Are the Treatments Tested in This Trial?

Interventions

• Pentoxifylline Oral Product
• Placebo

Trial Overview The study tests if Pentoxifylline can reduce red blood cell damage caused by the Impella heart pump in patients with cardiogenic shock. Participants will be randomly assigned to receive either Pentoxifylline or a placebo while their hemolysis levels are monitored.

How Is the Trial Designed?

Group I: Pentoxifylline Arm Experimental Treatment 1 Intervention

Pentoxifylline (in suspension with SyrSpend SF)

Group II: Placebo Arm Placebo Group 1 Intervention

Placebo (SyrSpend SF only)

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

ACE inhibitors are the most effective class of drugs for improving survival in chronic heart failure patients, regardless of the disease stage, and are currently being studied for their dose-effect relationship.

While beta-blockers enhance quality of life and physical performance, they have not shown a mortality benefit, and phosphodiesterase inhibitors, despite improving quality of life, are associated with increased mortality and are not recommended for heart failure treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of chronic heart failure: current views]. Komajda, M.[2009]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15832667/

Pentoxifylline for heart failure: a systematic review The use of pentoxifylline was associated with significant improvement in symptoms (i.e. NYHA functional class) and cardiac function (i.e. LVEF) in 3 out of 4 ...

2. ahajournals.org ahajournals.org/doi/10.1161/01.CIR.103.8.1083

Beneficial Effects of Pentoxifylline in Patients With ... In the present study, we show that the addition of pentoxifylline to treatment with digoxin, ACE inhibitors, and carvedilol results in a significant ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK71817/

Pentoxifylline for heart failure: a systematic review - NCBI The authors concluded that pentoxifylline may improve cardiac function and mortality, but there was insufficient evidence to draw firm conclusions and further ...

4. openheart.bmj.com openheart.bmj.com/content/3/1/e000365

Pentoxifylline for vascular health: a brief review of the ... Improved outcomes in congestive heart failure​​ The favourable effects of pentoxifylline on inflammation and blood rheology have prompted a ...

5. tandfonline.com tandfonline.com/doi/full/10.2144/fsoa-2023-0266

Effect of pentoxifylline on endothelial dysfunction, oxidative ... PTX for 2 months in STEMI patients was safe and well-tolerated but had no significant detectable effect on ED, oxidative stress or inflammatory markers.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24758396/

Pentoxifylline in heart failure: a meta-analysis of clinical trials The pooled data including 221 patients showed a nearly fourfold reduction in mortality (5.4% vs. 18.3%; OR 0.29; CI 0.12-0.74; P < 0.01) with homogenous results ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4746528/

Pentoxifylline for vascular health: a brief review of the ... Improved outcomes in congestive heart failure​​ The favourable effects of pentoxifylline on inflammation and blood rheology have prompted a ...

8. researchgate.net researchgate.net/publication/261836911_Pentoxifylline_in_Heart_Failure_A_Meta-Analysis_of_Clinical_Trials

Pentoxifylline in Heart Failure: A Meta‐Analysis of Clinical ... A meta-analysis done on six trials concluded that pentoxifylline reduced all-cause mortality in heart failure patients [46] .