Back to results

Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ubiquinol

Placebo

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Active

Arm Description

Placebo three times daily

Pills of 100 mg ubiquinol three times daily

Outcomes

Primary Outcome Measures

Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography

NT-pro brain natriuretic peptide (NT-proBNP) serum levels (pg/ml)

Secondary Outcome Measures

Full Information

NCT ID

NCT02779634

First Posted

May 15, 2016

Last Updated

May 18, 2016

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT02779634

Brief Title

Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo three times daily

Arm Title

Active

Arm Type

Active Comparator

Arm Description

Pills of 100 mg ubiquinol three times daily

Intervention Type

Drug

Intervention Name(s)

ubiquinol

Other Intervention Name(s)

coenzyme Q10

Intervention Description

Ubiquinol three times daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Sugar pill three times daily

Primary Outcome Measure Information:

Title

Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography

Time Frame

4 months

Title

NT-pro brain natriuretic peptide (NT-proBNP) serum levels (pg/ml)

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sara Elias

sarae@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Leibowitz, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34826125

Citation

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.

Results Reference

derived

Learn more about this trial

Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

We'll reach out to this number within 24 hrs