Congestive Heart FailurePENT-CHFNCT01337349
Effects of Pentoxiphylline on Left Ventricular (LV) Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure (CHF)
A study testing Pentoxifylline in people with Congestive Heart Failure, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Placebo, Pentoxifylline
- Keywords
- Pentoxifylline, Chronic Congestive Heart Failure, Left Systolic Function, Biomarkers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Sugar Pill 400mg taken orally three times a day for 6 months
PentoxifyllineDrug
Also called Trental
Pentoxifylline 400mg taken orally Three times a day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Placebo control Group with sugar pill three times daily for 6 months Receives: Drug: Placebo |
| Pentoxifylline | Experimental | Pentoxifylline 400mg tablets to be taken three times daily for 6 months Receives: Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Left Ventricular End Systolic Volume Index
Improvement in Left Ventricular End Systolic Volume Index (decrease of 10%) as measured by 2D echo
Measured: 6 months
Left Ventricular End Diastolic Volume Index
Improvement in Left Ventricular End Diastolic Volume Index (decrease of 10%) as measured by 2D echo
Measured: 6 Months
Quality of Life Improvement
Improvement in Quality of Life as Quantified by the Kansas City Heart Failure Questionaire.
Measured: 6 Months
Circulating Inflammatory Biomarkers
Improvement in Circulating Inflammatory Biomarkers (e.g. TNF, IL6).
Measured: 6 Months
Change in VO2 Max
Change in VO2 max over the study period. (With a change of 1 ml/kg/min as measured by cardiopulmonary exam considered meaningful.)
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJul 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Did not enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthikeyan Ananthasubramaniam, Henry Ford Health System
- Investigators
- Karthikeyan Ananthasubramaniam, MD, Principal investigator, Henry Ford Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337349
- Sponsor's protocol ID
- 2192010
- Acronym
- PENT-CHF
- Status last verified
- Jul 2022
- First submitted
- 15 Apr 2011
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pentoxiphylline on Left Ventricular Systolic Function Indices and Circulating Biomarkers in Patients With Chronic Congestive Heart Failure.
- ClinicalTrials.gov ID
- NCT01337349
- Acronym / sponsor ID
- PENT-CHF / 2192010
- Conditions
- Congestive Heart Failure
- Keywords
- Pentoxifylline, Chronic Congestive Heart Failure, Left Systolic Function, Biomarkers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: PlaceboPlacebo control Group with sugar pill three times daily for 6 months |
| Pentoxifylline | Experimental | Drug: PentoxifyllinePentoxifylline 400mg tablets to be taken three times daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSugar Pill 400mg taken orally three times a day for 6 months | Drug | Sugar Pill |
| PentoxifyllineAlso: TrentalPentoxifylline 400mg taken orally Three times a day for 6 months | Drug | Pentoxifylline |
Primary outcome
Improvement in Left Ventricular Ejection Fraction > 5%
Time frame: 6 months
Improvement in Left Ventricular Ejection Fraction > 5% (i.e: 20 to 25%) measured by SPECT MUGA after 6 months of pentoxifylline use.
5 secondary outcomes
Left Ventricular End Systolic Volume Index
Time frame: 6 months
Left Ventricular End Diastolic Volume Index
Time frame: 6 Months
Quality of Life Improvement
Time frame: 6 Months
Circulating Inflammatory Biomarkers
Time frame: 6 Months
Change in VO2 Max
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karthikeyan Ananthasubramaniam, MD principal investigator
Henry Ford Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline in people with Congestive Heart Failure, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Left Ventricular Ejection Fraction > 5% (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.