Randomized, Double Blind, Placebo Controlled Trial of Hydrosoluble Ubiquinol and Carnitine in Patients with Heart Failure: Longterm Follow up Results in the Tishcon Study

ABSTRACT

Carnitine and coenzyme Q10 are important for myocardial- mitochondrial function, and are deficient in patients with congestive heart failure. It is possible that supplementation with ubiquinol + l- carnitine may be protective among these patients, which may improve the quality of life and morbidity in heart failure.

In this controlled trial, the effects of carni Q-gel (L-carnitine fumarate 2250mg/day+hydrosoluble reduced ubiquinol 270mg/day) were examined for 15 months, in 31 (intervention group A) and another 31(control group B) patients with heart failure. Hospitalization due to worsening of heart failure, heart transplantation, and deaths were the combined endpoints.

Echo cardiographic ejection fraction was lower at baseline (38.8±7.6 v/s 39.3±6.7%) among both the group of patients, indicating class II- IV heart failure.

Baseline serum CoQ10 (0.21±0.11 v/s 0.19+0.10ug/ml) was low, however, after 12 weeks, serum CoQ showed a significant increase in the carniqgel group compared to the control group (2.7±1.2 v/s 0.76±0.14 ug/ml). After treatment for 12 months, the quality of life visual analogous scale revealed that dyspnea, palpitation and fatigue and NYHA class II-III-IV, which were present at rest, in all the patients, at baseline, showed beneficial effects in the intervention group compared to the placebo group. Six minutes walk test showed that there was a significant greater benefit in walking in the intervention group (215±17.6 v/s 281±20.6, P<0.02) compared to the placebo group (218.4±17.6 v/s 245.7±17.1, P<0.05). A change in the symptom scale showed that majority of the patients had improvement in the intervention group compared to the control group respectively (28 v/s 12 patients, P<0.02). The deaths (3 vs 8) and hospitalizations due to worsening of heart failure (2 vs 11) among intervention and control group respectively, were significantly lower in the carniqgel group compared to the control group (5 vs 19, P<0.02). Five patients had nausea and vomiting, which were controlled with symptomatic treatment. Treatment with carniqgel was stopped after 12 months. Follow up after another 3 months (total 15 months) revealed that there was a worsening of NYHA class heart failure, as well as in the quality of life symptom scale and physical performance, assessed by 6-min walk test. There was a nonsignificant increase in hospitalizations in the intervention group after cessation of carniqgel softsules, compared to hospitalizations during the last 3 months.

The findings indicate that treatment with ubiquinol +L-carnitine fumarate can cause a significant improvement in the quality of life, exercise capacity, as well as NYHA heart failure, which became worst after cessation of CoQ. There was a significant greater benefit in combined endpoints (hospitalization and deaths) in the intervention group than in the control group.

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