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Pentoxifylline for Heart Failure

Phase 4
Waitlist Available
Led By Domininc Emerson, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Heart failure patients who undergo axillary Impella 5.0 or 5.5 insertion for acute decompensated heart failure
Age >/= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post-device implant
Awards & highlights

Study Summary

This trial is testing whether the drug pentoxifylline can reduce hemolysis (breakdown of red blood cells) in people with acute decompensated heart failure who require a mechanical circulatory support device.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Pentoxifylline may cause side effects like nausea, dizziness, and headaches. In some cases, it might also lead to abnormal heartbeat rhythms or low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have heart failure and had an Impella device inserted for worsening symptoms.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-device implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post-device implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in REBC hemolysis
Secondary outcome measures
bleeding
death
device malfunction
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pentoxifylline ArmExperimental Treatment1 Intervention
Pentoxifylline (in suspension with SyrSpend SF)
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo (SyrSpend SF only)

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,807 Total Patients Enrolled
12 Trials studying Heart Failure
10,054 Patients Enrolled for Heart Failure
Domininc Emerson, MDPrincipal InvestigatorCedars-Sinai Medical Center; Smidt Heart Institute

Media Library

Pentoxifylline Oral Product (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04391231 — Phase 4
Heart Failure Research Study Groups: Pentoxifylline Arm, Placebo Arm
Heart Failure Clinical Trial 2023: Pentoxifylline Oral Product Highlights & Side Effects. Trial Name: NCT04391231 — Phase 4
Pentoxifylline Oral Product (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04391231 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How has Pentoxifylline Oral Product been demonstrated to be secure for patients?

"The safety of Pentoxifylline Oral Product is rated highly at 3 since it has recently achieved Phase 4 status, signifying that this medication has been approved by regulatory bodies."

Answered by AI

What ailments can Pentoxifylline Oral Product ameliorate?

"Pentoxifylline Oral Product has proven to be a successful remedy for alcoholic liver diseases, venous leg ulcers (VLUs), and intermittent claudication."

Answered by AI

What research has been conducted regarding Pentoxifylline Oral Product's efficacy?

"Currently, 10 investigations are underway concerning Pentoxifylline Oral Product. Three of these clinical trials have reached the 3rd phase; 27 different medical centres across Memphis, Tennessee are hosting them."

Answered by AI

Can individuals currently participate in this clinical experiment?

"According to the clinicaltrials.gov site, this trial is currently not accepting participants; although it was initially posted on September 15th 2021 and modified at last August 17th 2021, there are now 65 other medical studies enrolling patients right away."

Answered by AI

What is the aggregate number of people taking part in this experiment?

"At present, the trial is no longer recruiting patients. It was first posted on September 15th 2021 and last updated on August 17th 2021. If you are searching for other trials that may be suitable, there are presently 55 studies related to hemolysis actively enrolling participants and 10 clinical trials utilizing Pentoxifylline Oral Product currently accepting applicants."

Answered by AI
Recent research and studies
~14 spots leftby Apr 2025