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
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
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
No
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
No
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
Email
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
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