Condition category
Circulatory System
Date applied
21/02/2018
Date assigned
02/03/2018
Last edited
22/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 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 trial start date

01/04/2017

Overall trial end date

01/09/2018

Reason abandoned (if study stopped)

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

https://fk.undip.ac.id/

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes