CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jun 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a combination of exercise and a supplement called CoQ10 can improve health in patients with end-stage renal disease (ESRD), which means their kidneys are not working well. The researchers believe that problems with tiny parts of our cells called mitochondria might make it harder for patients to gain muscle strength and improve their physical abilities through exercise. The study aims to see if adding CoQ10 to high-intensity exercise can help boost the benefits of working out, potentially preventing issues like weakness and loss of muscle.

To be eligible for this trial, participants need to be between 18 and 75 years old and have been on hemodialysis (a treatment for kidney failure) for at least six months. They should also be stable and receiving the right amount of dialysis. However, certain health conditions, such as severe obesity, heart disease, or active infections, may exclude someone from participating. Those who join the study can expect to engage in exercise routines combined with CoQ10 supplementation, with the hope of improving their overall physical performance and health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects age 18 to 75 years
• • On thrice-weekly chronic hemodialysis for at least 6 months (only applicable for patients with ESRD on maintenance hemodialysis).
• • Clinically stable, adequately dialyzed (single-pool Kt/V \>1.2) thrice weekly, for at least 3 consecutive months prior to the study (only applicable for patients with ESRD on maintenance hemodialysis)
• Exclusion Criteria:
• • Body mass index \> 35 mg/kg2
• • History of functional transplant less than 6 months prior to study
• • Use of immunosuppressive drugs within 1 month prior to study
• • Active connective tissue disease
• • Acute infectious disease within 1 month prior to study
• • AIDS (HIV seropositivity is not an exclusion criterion)
• • Acute myocardial infarction or cerebrovascular event within 3 months
• • Uncontrolled blood pressure
• • New or worsening mitral regurgitation murmur
• • Hypotension, bradycardia, or tachycardia
• • Prolonged ongoing (greater than 20 minutes) angina at rest
• • Angina at rest with transient ST changes greater than 0.05 mV on ECG
• • Sustained ventricular tachycardia on ECG
• • Elevated cardiac enzymes (e.g., troponin Tor I greater than 0.1mg/ml)
• • Advanced liver disease, with a modified Child-Turcotte-Pugh score equal or greater than 10.
• • Gastrointestinal dysfunction requiring parental nutrition
• • Active malignancy excluding basal cell carcinoma of the skin
• • Ejection fraction less than 30%
• • Pre-dialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
• • Anticipated live donor kidney transplant
• • History of poor adherence to hemodialysis or medical regimen
• • Inability to provide consent
• • Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies.
• • Inability to perform exercise
• • Contraindication for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion.