Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02779634
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 18

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: ubiquinol; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Ubiquinol Treatment on Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction
• Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2018
• Anticipated Study Completion Date: Jan 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography [4 months]

2. NT-pro brain natriuretic peptide (NT-proBNP) serum levels (pg/ml) [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEIBOWITZ DAVID, Associate professor of medicine Hadassah-Hebrew University Medical Center, Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT02779634
• Other Study ID Numbers: COENZYMEQ
• First Posted: May 20, 2016
• Last Update Posted: May 20, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Heart Failure; Coenzyme Q10

Study Results

No Results Posted as of May 20, 2016