Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02779634
• Other study ID #: COENZYMEQ
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 15, 2016
• Last updated: May 18, 2016
• Start date: July 2016
• Est. completion date: January 2018

Study information

• Verified date: May 2016
• Source: Hadassah Medical Organization
• Contact: Sara Elias
• Email: sarae[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• ubiquinol
Ubiquinol three times daily
• Placebo
Sugar pill three times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography		4 months	No
Primary	NT-pro brain natriuretic peptide (NT-proBNP) serum levels (pg/ml)		4 months	No