Effects of Pentoxiphylline on Left Ventricular (LV) Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure (CHF)

NCT01337349 | Withdrawn

• 1 other identifier: 2192010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, double blinded randomized clinical study to evaluate the Effects of Pentoxifylline on left ventricular systolic function indices and circulating biomarkers in patients with chronic congestive heart failure. A few studies all focused in Africa have consistently shown marked beneficial effects of pentoxifylline in improvement of left ventricular size and systolic function along with marked decrease in biomarkers of heart failure and apoptosis markers on top of standard CHF therapy. Furthermore pentoxifylline was shown to have negligible effects on heart rate, blood pressure in those studies. Limitations of these studies are that they are largely single center originating in the African subcontinent and have never been tested in the North American population, particularly Caucasians. Despite major advances in medical therapy for congestive heart failure, it is still one of the leading causes of morbidity and mortality in North America. Most medications tested for improvement of Ejection Fraction with the exception of Beta-Blockers and Ace-Inhibitors have been associated with worsening mortality. Pentoxifylline is a medication that has negligible effects on myocardial oxygen consumption, yet promising effects on inflammatory markers seen in CHF with the possibility of improvement in LV systolic function and symptomology and may prove to be a useful addition for CHF patients. This would prove to be especially useful, particularly when associated with no major side effects.

Conditions

Congestive Heart Failure

Keywords

Pentoxifylline; Chronic Congestive Heart Failure; Left Systolic Function; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Improvement in Left Ventricular Ejection Fraction > 5%

  Improvement in Left Ventricular Ejection Fraction \> 5% (i.e: 20 to 25%) measured by SPECT MUGA after 6 months of pentoxifylline use.

  6 months

Secondary Outcomes (5)

• Left Ventricular End Systolic Volume Index

  6 months

• Left Ventricular End Diastolic Volume Index

  6 Months

• Quality of Life Improvement

  6 Months

• Circulating Inflammatory Biomarkers

  6 Months

• Change in VO2 Max

  6 Months

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Placebo control Group with sugar pill three times daily for 6 months

Drug: Placebo

Pentoxifylline

EXPERIMENTAL

Pentoxifylline 400mg tablets to be taken three times daily for 6 months

Drug: Pentoxifylline

Interventions

Placebo DRUG

Sugar Pill 400mg taken orally three times a day for 6 months

Sugar Pill

Pentoxifylline DRUG

Pentoxifylline 400mg taken orally Three times a day for 6 months

Also known as: Trental

Pentoxifylline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-ischemic and ischemic class II-III heart failure patients on maximally tolerated evidence based medications. (i.e. BB (coreg, toprol, bisoprolol), ACEI/ARBS, Diuretics, +/- aldactone, digoxin).
• Patients should also have an expected survival of greater than 6 months, including all other co-morbidities.
• Sinus Rhythm
• Age \>18
• LVEF \<40% as assessed by (SPECT MUGA, ECHO).

You may not qualify if:

• Class I and Class IV heart failure patients, patients who are newly diagnosed and currently are not on traditional evidence based medications.
• Patients who have BiV-ICD placement.
• Patients who decompensate into class IV heart failure during the study period requiring inotropes, LVAD, upgrade to BiV-ICD, will be reported on for potential treatment failure but will be taken out of the study.
• Patients whose clinical conditions other than cardiomyopathy could influence inflammatory biomarkers. (i.e. Connective Tissue disorders, HIV)
• Pregnancy
• Severe exercise induced malignant ventricular arrhythmia
• Any systemic process other than cardiomyopathy that would lead to survival \<6 months

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Karthikeyan Ananthasubramaniam, MD

  Henry Ford Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Nuclear Cardiology and Echocardiography

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

US (1)