Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo three times daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill three times daily

Active

Pills of 100 mg ubiquinol three times daily

Group Type ACTIVE_COMPARATOR

ubiquinol

Intervention Type DRUG

Ubiquinol three times daily

Interventions

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ubiquinol

Ubiquinol three times daily

Intervention Type DRUG

Placebo

Sugar pill three times daily

Intervention Type DRUG

Other Intervention Names

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coenzyme Q10

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No