NCT01337349

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

Effects of Pentoxiphylline on Left Ventricular Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who meet inclusion criteria will have a baseline physical exam, Heart Failure status assessment based on the Kansas City Heart Failure Questionnaire, EF assessment based on SPECT MUGA, cardiopulmonary exam to evaluate Vo2 max and assessment of left ventricular end diastolic and systolic dimensions based on 2D echo and labs drawn to assess circulating biomarkers. Patients will than be randomized into the control population where they will receive a placebo medication vs. the study population who will receive pentoxiphylline 400mg three times daily for 6 months. Patients will also have a one and three month clinic visit to assess for any potential change in symptoms and to assess medication compliance. Patients will then have a 6 month follow-up with repeat physical exam, Heart Failure status assessment based on the Kansas City Heart Failure Questionnaire, EF assessment based on SPECT MUGA, cardiopulmonary exam to assess Vo2 Max and assessment of left ventricular end diastolic and systolic dimensions based on 2D echo and labs drawn to assess circulating biomarkers.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	Placebo	Sugar Pill 400mg taken orally three times a day for 6 months
DRUG	Pentoxifylline	Pentoxifylline 400mg taken orally Three times a day for 6 months

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-04-18
• Last updated: 2022-08-01

Locations

1 site across 1 country: United States