Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

NCT02779634 | Unknown Phase 2

• 1 other identifier: COENZYMEQ
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo three times daily

Drug: Placebo

Active

ACTIVE COMPARATOR

Pills of 100 mg ubiquinol three times daily

Drug: ubiquinol

Interventions

ubiquinol DRUG

Ubiquinol three times daily

Also known as: coenzyme Q10

Active

Placebo DRUG

Sugar pill three times daily

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (1)

• Samuel TY, Hasin T, Gotsman I, Weitzman T, Ben Ivgi F, Dadon Z, Asher E, Amir O, Glikson M, Alcalai R, Leibowitz D. Coenzyme Q10 in the Treatment of Heart Failure with Preserved Ejection Fraction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. Drugs R D. 2022 Mar;22(1):25-33. doi: 10.1007/s40268-021-00372-1. Epub 2021 Nov 26.

  PMID: 34826125 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

ubiquinol; coenzyme Q10

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• David Leibowitz, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Elias

CONTACT

sarae@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of medicine Hadassah-Hebrew University Medical Center

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 20, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 20, 2016

Record last verified: 2016-05