Phase 2 N=153 Randomized Double-blind Treatment

CoQ10 and D-ribose in Patients With Diastolic Heart Failure

Heart Failure, Diastolic

Bottom Line

View on ClinicalTrials.gov: NCT03133793 ↗

Enrolled (actual)

153

Serious AEs

21.6%

Results posted

Mar 2022

Primary outcome: Primary: Change in Health Status of Patients With HFpEF — 4.15; 26.56; 29.97; 33 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CoQ10 (Drug); D-Ribose Oral Powder (Drug); Placebo pills (Other); Placebo powder (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of Kansas Medical Center
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Health Status of Patients With HFpEF	4.15; 26.56; 29.97; 33	—
SECONDARY Change in Vigor	-0.54; 7.11; 7.3; 7.61	—
SECONDARY Change in Ejection Fraction (EF)	-2.39; 4.69; 5.64; 5.07	—
SECONDARY Change in Septal E/e'	1.39; -1.27; -0.65; -0.47	—
SECONDARY Change in 6 Minute Walk Test (6MWT)	19.62; 21.21; 29.42; 36.21	—
SECONDARY Change in Venous Blood B-type Natriuretic Peptide (BNP) Levels	-18.43; -29.56; -42.94; 29.08	—
SECONDARY Change in Lactate	0.33; 0; -0.35; -0.24	—
SECONDARY Change in Adenosine Triphosphate (ATP)	-189.08; 1133.5; 907.44; 686.19	—

Summary

The purpose of this study is to compare the clinical benefits of CoQ10 and D-ribose taken by patients who have diastolic heart failure, or heart failure with preserved ejection fraction (HFpEF).

Eligibility Criteria

Inclusion Criteria

Diagnosed with HFpEF within a 6-month period
New York Heart Association (NYHA) Classification II-III HF
Have left ventricular ejection fraction (EF) ≥ 50% documented by an echocardiogram
Have a telephone or reliable phone contact
Have their own means of transportation to the study site

Exclusion Criteria

Acute coronary syndrome in the past 12 weeks
Significant valvular heart disease
Severe cardiac fibrosis (galectin-3 level > 26 ng/ml)
Constrictive pericardium
Pulmonary fibrosis
Congenital heart disease
Hypertrophic or infiltrative cardiomyopathy
Heart transplant
Left ventricular assist device
Heart failure (HF) associated hospital admission or emergency room visit within past 30 days
Recent percutaneous coronary intervention
Significant renal and/or hepatic dysfunction
Severe cognitive impairment
Consumption of any CoQ10 (ubiquinol) or D-ribose supplements

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03133793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.