Effects of Pentoxiphylline on Left Ventricular (LV) Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure (CHF)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2010 |
| End Date: | July 2014 |
| Contact: | Karthikeyan Ananthasubramaniam, MD |
| Email: | kananth1@hfhs.org |
| Phone: | 313-916-2721 |
Effects of Pentoxiphylline on Left Ventricular Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure.
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.
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.
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.
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.
Inclusion Criteria:
1. 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).
2. Patients should also have an expected survival of greater than 6 months, including
all other co-morbidities.
3. Sinus Rhythm
4. Age >18
5. LVEF <40% as assessed by (SPECT MUGA, ECHO).
Exclusion Criteria:
1. Class I and Class IV heart failure patients, patients who are newly diagnosed and
currently are not on traditional evidence based medications.
2. Patients who have BiV-ICD placement.
3. 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.
4. Patients whose clinical conditions other than cardiomyopathy could influence
inflammatory biomarkers. (i.e. Connective Tissue disorders, HIV)
5. Pregnancy
6. Severe exercise induced malignant ventricular arrhythmia
7. Any systemic process other than cardiomyopathy that would lead to survival <6 months
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