Effect of carni Q-gel (ubiquinol and carnitine) on cytokines in patients with heart failure in the TISHCON study
| ISRCTN | ISRCTN89073451 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89073451 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/03/2007
- Registration date
- 30/03/2007
- Last edited
- 08/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adarsh Kumar
Scientific
Scientific
Professor and Head of the Department of Cardiology
Government Medical College Amritsar
Punjab
143001
India
| adarshk27@jla.vsnl.net.in |
Study information
| Study design | Double blind, placebo controlled, randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | The TISHCON Study |
| Study objectives | Chronic Heart Failure (CHF) represents a major public health burden, and its prognosis is comparable to that of different malignant diseases. CHF progresses because of the activation of neurohormones and pro-inflammatory cytokines, as well as coenzyme Q10 (CoQ) deficiency, following an initial cardiac injury such as Acute Myocardial Infarction (AMI), statin toxicity or a mutation of the genetic programme. It is becoming increasingly apparent that inflammatory mediators play a crucial role in the development of CHF and AMI and several strategies to counterbalance different aspects of the inflammatory response are considered. Possible targets involve pro-and anti-inflammatory cytokines and their receptors, endotoxin, adhesion molecules, nitric oxide and nitric oxide synthase, reactive oxygen species, CoQ and L-carnitine in mitochondria and different types of leucocytes. The most important cytokines implicated in the progression of CHF are Tumour Necrosis Factor (TNF-alpha), Interleukin (IL)-1, and IL-6. These cytokines share some of their major characteristics (redundancy), and all act in a pro-inflammatory sense. Among those, TNF-alpha is the cytokine that has been studied in greatest detail. IL-10 is anti-inflammatory which is beneficial in heart failure. Cytokines form a vast array of relative low molecular weight, pharmacologically active proteins. These substances are secreted by different cell types for the purpose of altering either their own function (autocrine) or that of adjacent cells (paracrine). Several hypotheses have been suggested to describe the origin of immune activation in CHF. The production of pro-inflammatory cytokines has mostly been attributed to secretion by mononuclear cells, although the myocardium seems to be another important source. Some evidence suggests that catecholamines augment this myocardial cytokine production. There is evidence that CoQ and carnitine may be beneficial in patients with heart failure. In the present study, we examine, that ubiquinol, in conjunction with L-carnitine, can decrease cytokines and may be useful in patients with CHF. |
| Ethics approval(s) | Reviewed and approved by the Institutional Ethics Committee at Government Medical College, Amritsar, India on the 28th August 2005. |
| Health condition(s) or problem(s) studied | Chronic Heart Failure |
| Intervention | Nine carni Q-gel softgels (three with each meal thrice daily), which provide a total of 270 mg ubiquinol and 2250 mg L-carnitine daily, or nine matching placebos were administerd to each patient, during the period of 12 weeks. All patients were kept on standard drug therapy, and carni Q-gel and placebo were used as adjuncts to regular drug therapy not as a replacement or substitute. Laboratory data: Baseline measurements were taken and repeated after 12 weeks, and a complete blood profile was performed including: 1. Thiobarbituric Acid Reactive Substances (TBARS) and Malondialdehyde (MDA) were obtained by colorimetric methods 2. Resting electrocardiogram and prothrombin time (on anticoagulants) were performed in all the patients at baseline and during follow up whenever indicated 3. CoQ levels in the serum were measured by high pressure liquid chromatography based on an earlier method at Tishcon Corporation (USA) 4. Cytokines Interleukin-six (IL-6), Interleukin-ten (IL-10) and Tumour Necrotising Factors (TNF)-alpha were determined by using a solid phase, two sided chemiluminescence enzyme immunometric assay (immulite automated analyser) kit The serum samples were kept at -24°C until assay. Results were expressed in pg/ml. The technicians measuring the laboratory data were blind to the groups. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ubiquinol and carnitine |
| Primary outcome measure | 1. Increase in distance walked in six minutes 2. NYHA class of heart failure 3. Echocardiographic cardiac size |
| Secondary outcome measures | Reduction in TNF-alpha and IL-6 |
| Overall study start date | 01/09/2005 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 62 |
| Key inclusion criteria | 1. Both men and women affected by Chronic Heart Failure (CHF) of mixed etiology 2. Ischaemic, hypertensive, valvular heart disease and idiopathic dilated cardiomyopathy 3. Severity of disease was assessed by New York Heart Association (NYHA) functional Class II to IV |
| Key exclusion criteria | 1. Hypertrophic cardiomyopathy 2. Amyloid cardiomyopathy 3. Not willing to give consent 4. Patients presenting with shock 5. Chronic renal failure 6. Cancer |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- India
Study participating centre
Professor and Head of the Department of Cardiology
Punjab
143001
India
143001
India
Sponsor information
Tishcon Corporation (USA)
Industry
Industry
c/o Mr Raj K Chopra
Westbury
New York
11590
United States of America
| Phone | +1 516 333 3050 |
|---|---|
| Raj@Tishcon.com | |
| Website | http://www.tishcon.com/ |
"ROR" |
https://ror.org/0133gy560 |
Funders
Funder type
Industry
Tishcon Corporation (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2007 | Yes | No |
