Plain English Summary
Background and study aims
Heart failure occurs when the heart is not able to pump enough blood that the body needs. Heart failure with preserved ejection fraction (HFpEF) (a type of heart failure where the left ventricle pumps with each an amount of blood greater than 50%) is a leading cause of morbidity and mortality without an established best course treatment. Diastolic dysfunction (the decline of the performance of one of the ventricles) is a hallmark of HFpEF. This is associated with altered myocardial bioenergetics and oxidative stress. No previous study has examined the effects of coenzyme Q10, a bioenergizer and antioxidant, on left ventricle (LV) diastolic function of HFpEF patients. The aim of this study is to investigate the effects of coenzyme Q10 on LV diastolic function in HFpEF patients.
Who can participate?
Adults aged 45 and older who have heart failure.
What does the study involve?
Participants are allocated to one of two groups. Those in the first group receive a capsule of coenzyme Q10 (100 mg) three times a day for 30 days. Those in the second group continue with their usual care. Participants are assessed for their heart function after 30 days using an ECG and a blood test.
What are the possible benefits and risks of participating?
CoQ10 is available over the counter as a dietary supplement elsewhere. Potential benefits of CoQ10 supplementation have been recognized with particular reference to energy supplement and cardiovascular and neurodegenerative diseases. CoQ10 has an excellent safety record. The safety of high doses of orally-ingested CoQ10 over long periods is well documented in human subjects. The side effects reported in human studies are generally limited to mild gastrointestinal symptoms such as nausea and stomach upset seen in a small number of subjects. No adverse effects were observed with daily doses ranging from 600 to 1200 mg in two trials on Huntington’s and Parkinson’s diseases. In cardiovascular disease patients CoQ10 dosages generally range from 100 to 300 mg a day. Caution should be given to the patients who are taking Coumadin given the similarities of CoQ10 with vitamin K.
Where is the study run from?
dr. Kariadi Hospital (Indonesia)
When is the study starting and how long is it expected to run for?
April 2017 to September 2018
Who is funding the study?
Ministry of Research, Technology and Higher Education Indonesia
Who is the main contact?
1. Dr Mochamad Ali Sobirin (Scientific)
2. Dr Sodiqur Rifqi (Scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mochamad Ali Sobirin
ORCID ID
Contact details
Head of Department of Cardiology and Vascular Medicine
Faculty of Medicine
Diponegoro University
Semarang
50244
Indonesia
Type
Scientific
Additional contact
Dr Sodiqur Rifqi
ORCID ID
Contact details
Head of Department of Cardiology and Vascular Medicine
Faculty of Medicine
Diponegoro University
Semarang
50244
Indonesia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
486/EC/FK-RSDK/VII/2017
Study information
Scientific title
Effect of short term coenzyme Q10 supplementation on diastolic function in heart failure with preserved ejection fraction patients
Acronym
Study hypothesis
Coenzyme Q10 supplementation can improve left ventricular diastolic function in patients with heart failure with preserved ejection fraction.
Ethics approval
Head of Ethical Clearance in Faculty of Medicine, Diponegoro University, 01/08/2017: ref: 486/EC/FK-RSDK/VII/2017
Study design
Interventional single-centre randomised parallel unblinded study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, pelase use contact details to request a participant information sheet
Condition
Heart failure
Intervention
Eligible participants are randomly allocated to one of two groups. Those in the first group receive coenzyme Q10 100 mg three times a day in a capsule for 30 days. Those in the second group receive treatment as usual.
The randomization ratio was 1:1 for coenzyme Q10 or without coenzyme Q10 using permuted block. Standard therapies for risk factor and symptom control were at the discretion of treating physicians and required to be unchanged within the 4 weeks prior to randomization.
Follow up will be in every week and after 1 month by phone call or during hospital visit. Participants are also followed up with blood tests and ECGs.
Intervention type
Drug
Phase
Phase II
Drug names
Coenzyme Q10 (Qten 100 mg, by Novell pharmaceutical laboratories)
Primary outcome measures
Diastolic function is measured using the two dimensional and doppler echocardiography at baseline and 1 month after intervention.
Secondary outcome measures
1. Plasma malondialdehyde level is measured using HPLC procedure at baseline and 1 month after intervention
2. Quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at at baseline and 1 month after intervention
Overall trial start date
01/04/2017
Overall trial end date
01/09/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men or women and age > 45 years old
2. Typical signs and symptoms of chronic heart failure (CHF) (New York Association Class 2-3)
3. Normal ejection fraction on echocardiography (EF ≥50%)
4. Evidence of diastolic dysfunction on non-invasive imaging (at least diastolic dysfunction grade 1 (E/A ≤ 0.8 + E > 50 cm/s or E/A> 0.8 - < 2) with at least 1 criteria below required: (1) septal e׳< 7 cm/sec or lateral e׳< 10 cm/sec, (2) average E/e' > 14, (3) LA volume index > 34 ml/m2, and (4) TR velocity > 2.8 m/sec
5. Stable medical therapy for 4 weeks prior to randomization
6. Informed consent available
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Chronic atrial fibrillation
2. Acute coronary syndrome or coronary revascularization within 60 days
3. Clinically significant valvular disease
4. Significantly low systolic blood pressure (<100) mmHg and high blood pressure
5. Patients with a prior LVEF reading <40%
6. Known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease
7. Dyspnea or edema due to non-cardiac cause such as pulmonary disease, anemia (Hb < 8.0 g/dl)
8. Any sign of serious infection during study
9. On treatment of corticosteroid and immunosupresant drugs
10. Current smoker more than 30 cigarettes/day
11. Inability/refusal to provide informed consent
12. Poor echo window
Recruitment start date
01/11/2017
Recruitment end date
01/02/2018
Locations
Countries of recruitment
Indonesia
Trial participating centre
dr. Kariadi Hospital
dr. Sutomo Road No.16
Semarang
50244
Indonesia
Sponsor information
Organisation
Diponegoro University
Sponsor details
Faculty of Medicine
Prof Sudarto SH Road
Tembalang
Semarang
50275
Indonesia
+62 247 692 8010
dr_alibirin@yahoo.com
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Ministry of Research, Technology and Higher Education Indonesia
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. Additional documentation is available in PDF format.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Mochamad Ali Sobirin, MD, PhD (email: dr_alibirin@yahoo.com)
Intention to publish date
01/06/2018
Participant level data
Available on request
Results - basic reporting
Publication summary