Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

Phase 2

• Conditions: Heart Failure
• Interventions: Drug: Placebo; Drug: ubiquinol

• Registration Number: NCT02779634
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-15
• Study First Submitted QC: 2016-05-18
• Last Update Submitted: 2016-05-18
• Study First Posted: 2016-05-20
• Last Update Posted: 2016-05-20
• Study Start: 2016-07
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo three times daily
Active	ubiquinol	Pills of 100 mg ubiquinol three times daily

Primary Outcome Measures

Name	Time	Method
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