Effects of Pentoxiphylline on Left Ventricular (LV) Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure (CHF) (PENT-CHF)
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Pentoxiphylline on Left Ventricular Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure.|
- Improvement in Left Ventricular Ejection Fraction > 5% [ Time Frame: 6 months ] [ Designated as safety issue: No ]Improvement in Left Ventricular Ejection Fraction > 5% (i.e: 20 to 25%) measured by SPECT MUGA after 6 months of pentoxifylline use.
- Left Ventricular End Systolic Volume Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]Improvement in Left Ventricular End Systolic Volume Index (decrease of 10%) as measured by 2D echo
- Left Ventricular End Diastolic Volume Index [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Improvement in Left Ventricular End Diastolic Volume Index (decrease of 10%) as measured by 2D echo
- Quality of Life Improvement [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Improvement in Quality of Life as Quantified by the Kansas City Heart Failure Questionaire.
- Circulating Inflammatory Biomarkers [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]Improvement in Circulating Inflammatory Biomarkers (e.g. TNF, IL6).
- Change in VO2 Max [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Change in VO2 max over the study period. (With a change of 1 ml/kg/min as measured by cardiopulmonary exam considered meaningful.)
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sugar Pill
Placebo control Group with sugar pill three times daily for 6 months
Sugar Pill 400mg taken orally three times a day for 6 months
Pentoxifylline 400mg tablets to be taken three times daily for 6 months
Pentoxifylline 400mg taken orally Three times a day for 6 months
Other Name: Trental
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337349
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Karthikeyan Ananthasubramaniam, MD||Henry Ford Health Systems|