Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

May 18, 2016 updated by: LEIBOWITZ DAVID, Hadassah Medical Organization

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo three times daily
Drug: Placebo
Sugar pill three times daily
Active Comparator: Active
Pills of 100 mg ubiquinol three times daily
Drug: ubiquinol
Ubiquinol three times daily
Other Names:
  • coenzyme Q10

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: David Leibowitz, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

May 15, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COENZYMEQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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