Suspended

Ubiquinol Therapy Impact on Diastolic Function in Elderly Heart Failure Patients with Preserved Ejection Fraction

Study Aim

This phase 2 study aims to evaluate the impact of Ubiquinol therapy on heart function, specifically diastolic function, in elderly patients with heart failure who have a preserved ejection fraction, by observing changes in mitral valve inflow and tissue Doppler velocities on echocardiography and NT-pro brain natriuretic peptide (NT-proBNP) serum levels.

What is being tested

ubiquinol

+ Placebo

Drug

Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 50 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: July 2016

See protocol details

Summary

Principal SponsorHadassah Medical Organization

Study ContactSara Elias

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2016

Actual date on which the first participant was enrolled.

This study focuses on understanding the effects of a treatment called Ubiquinol on heart function in elderly patients with a specific type of heart failure known as Heart Failure with Preserved Ejection Fraction (HFPEF). Currently, there's a lack of research on how a substance called coenzyme Q (CoQ) impacts heart function in these patients. This study aims to fill this gap, potentially improving care for those with HFPEF. Participants in this study will receive Ubiquinol, which is a form of CoQ with better absorption, for a period of 16 weeks. The study will measure changes in heart function using echocardiography, a type of ultrasound test that uses sound waves to create pictures of the heart. It will also evaluate levels of a specific protein called NT-pro brain natriuretic peptide (NT-proBNP) in the blood, which is a common indicator of heart function.

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

NCT02779634

Principal SponsorHadassah Medical Organization

Study ContactSara Elias

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

4 inclusion criteria required to participate

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

5 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Pills of 100 mg ubiquinol three times daily

Group II

Placebo

Placebo three times daily

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers