Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

The Effect of Ubiquinol Treatment on Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02779634

Enrollment

Registered

2016-05-20

Start date

2016-07-31

Completion date

2018-01-31

Last updated

2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on echocardiographic indices of diastolic function in elderly patients with heart failure with preserved ejection fraction (HFPEF). In previous studies the only echocardiographic parameters studied were ejection fraction (EF) and chamber size. The objective of the proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic function assessed by echocardiography in patients over the age of 50 with a clinical diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be utilized for this study as it has been shown to have superior bioavailability when compared to oxidized CoQ.

Interventions

DRUGubiquinol

Ubiquinol three times daily

DRUGPlacebo

Sugar pill three times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Typical signs and symptoms of congestive heart failure (CHF) (New York Association Class 2-4). * Normal ejection fraction on echocardiography (EF ≥50%). * Evidence of diastolic dysfunction on non-invasive imaging (E:e' \> 15 or e:e' \> 8 with other measures of diastolic dysfunction such as e/a \< 0.5 with elevated deceleration time or left atrial volume index \> 40 cc/m2 or presence of elevated left ventricular mass index or elevated pulmonary pressures). * Stable medical therapy for 4 weeks prior to randomization

Exclusion criteria

* Chronic atrial fibrillation. * Acute coronary syndrome or coronary revascularization within 60 days. * Clinically significant valvular disease. * Known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease. * Inability/refusal to provide informed consent

Design outcomes

Primary

Measure	Time frame
Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography	4 months
NT-pro brain natriuretic peptide (NT-proBNP) serum levels (pg/ml)	4 months

Contacts

Primary ContactSara Elias

sarae@hadassah.org.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026