Coenzyme Q10 supplementation in heart failure with preserved ejection fraction patients

ISRCTN	ISRCTN96610559
DOI	https://doi.org/10.1186/ISRCTN96610559
Secondary identifying numbers	486/EC/FK-RSDK/VII/2017

Submission date: 21/02/2018
Registration date: 02/03/2018
Last edited: 22/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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)

Contact information

Dr Mochamad Ali Sobirin
Scientific

Head of Department of Cardiology and Vascular Medicine, Faculty of Medicine
Diponegoro University
Semarang
50244
Indonesia

Dr Sodiqur Rifqi
Scientific

Head of Department of Cardiology and Vascular Medicine
Faculty of Medicine, Diponegoro University
Semarang
50244
Indonesia

Study information

Study design	Interventional single-centre randomised parallel unblinded study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, pelase use contact details to request a participant information sheet
Scientific title	Effect of short term coenzyme Q10 supplementation on diastolic function in heart failure with preserved ejection fraction patients
Study objectives	Coenzyme Q10 supplementation can improve left ventricular diastolic function in patients with heart failure with preserved ejection fraction.
Ethics approval(s)	Head of Ethical Clearance in Faculty of Medicine, Diponegoro University, 01/08/2017: ref: 486/EC/FK-RSDK/VII/2017
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Coenzyme Q10 (Qten 100 mg, by Novell pharmaceutical laboratories)
Primary outcome measure	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 study start date	01/04/2017
Completion date	01/09/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Key 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
Key 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
Date of first enrolment	01/11/2017
Date of final enrolment	01/02/2018

Locations

Countries of recruitment

Indonesia

Study participating centre

dr. Kariadi Hospital

dr. Sutomo Road No.16
Semarang
50244
Indonesia

Sponsor information

Diponegoro University
University/education

Faculty of Medicine
Prof Sudarto SH Road
Tembalang
Semarang
50275
Indonesia

Phone	+62 247 692 8010
Email	dr_alibirin@yahoo.com
Website	https://fk.undip.ac.id/
"ROR"	https://ror.org/056bjta22

Funders

Funder type

Government

Ministry of Research, Technology and Higher Education Indonesia

No information available

Results and Publications

Intention to publish date	01/06/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal. Additional documentation is available in PDF format.
IPD sharing plan	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)