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Heart Failure, SystolicPhase 2NCT03073356

Ketones in Heart Failure - Effects on Cardiac Efficiency

A Phase 2 study testing Infusion of 3-OHB in people with Heart Failure, Systolic and Ketonemia, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ketones may have beneficial effects on myocardial metabolism and hemodynamics. In the present study, healthy test subjects and patients with heart failure with reduced ejections fraction will be investigated in a randomized cross-over design with ketone infusions and placebo. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Heart Failure, Systolic, Ketonemia
What is being tested?
Infusion of 3-OHB
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteDenmark
Study dates
17 Mar 2017to 16 Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For participants with heart failure:
  • Symptoms of Heart failure NYHA 2-3
  • LVEF<40%
  • For all participants:
  • Negative HCG for women in the pregnant age

Who cannot join

  • Significant cardiac valve disease
  • Signs or history of major myocardial infarction (STEMI) within 3 months
  • Other disease or treatment making subject unsuitable for study participation
  • Treatment for diabetes or HbA1c level >7%

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Dept. of cardiology, Aarhus university hospital Skejby

    Aarhus, Central Jutland, 8200

Other trials in Denmark

About this study

Official title: Effects of Ketones on Cardiac Function and Oxygen Consumption in Heart Failure Patients With Reduced Ejection Fraction and Healthy Test Subjects

Ketones may have beneficial effects on myocardial metabolism and hemodynamics. In the present study, healthy test subjects and patients with heart failure with reduced ejections fraction will be investigated in a randomized cross-over design with ketone infusions and placebo. Myocardial efficiency and hemodynamics will be evaluated.

Read the detailed description

The prevalence of patients with heart failure and reduced ejection fraction (HFrEF) is 1-2%, and the lifetime risk of heart failure at age 55 years is approximately 30%. Despite advances in treatment, hospitalization rate and mortality remains high. It is well known that myocardial metabolism changes during development of HFrEF, and may contribute to contractile dysfunction. However, the myocardium can be considered an omnivore regarding substrate utilization, conferring an important adaptive property. Hence, it metabolizes either glucose, lipids, lactate, amino acids or ketones (3-hydroxybutyrate) depending on substrate availability, hormonal status and cardiac demands. These substrates differ with regard to myocardial energy efficiency (MEE) (cardiac work related to oxygen consumption). Since high MEE is associated with a better prognosis in HFrEF, manipulating substrate uptake could be a new treatment modality in heart failure patients.

Recently, it was shown that the human myocardium increases 3-hydroxybutyrate (3-OHB) metabolism during development of HFrEF. These changes may be beneficial as 3-OHB could increase myocardial efficiency and lower oxidative stress by scavenging free radicals. However, until now this has not been investigated in clinical trials, and the effect of 3-OHB on cardiac function, oxygen consumption and perfusion remains undetermined in HFrEF patients.

In the present study the investigators will evaluate whether elevated circulating 3-OHB affect myocardial oxygen consumption, MEE and perfusion in healthy subjects and patients with HFrEF, and whether 3-OHB affect hemodynamics and contractile function.

10 healthy test subjects and 20 HFrEF patients will be subjected to placebo and 3-OHB infusion in a randomized cross-over design. Acetate-PET, echocardiography and right sided heart catheterization will be applied.

Being tested
Infusion of 3-OHB, Infusion of placebo
Keywords
Myocardial metabolism, Positron emission tomography, Echocardiography, Right sided heart catheterization
Medical subject headings
Heart Failure, Systolic, Ketosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infusion of 3-OHBBiological

    Also called Na-3-OHB

    Increase in 3-OHB levels

  • Infusion of placeboBiological

    Also called NaCl

    NaCl

Study groups in NCT03073356
Study groupRoleWhat they receive
Control - Healthy test subjectsExperimentalAge matched subjects without symptoms of heart failure or ischemic heart disease N=10
Receives: Biological: Infusion of 3-OHB; Biological: Infusion of placebo
HFrEF - Heart failure patients investigated by PETExperimentalPatients with heart failure (HFrEF) N=12
Receives: Biological: Infusion of 3-OHB; Biological: Infusion of placebo
HFrEF - Right heart catheterizationExperimentalPatients with heart failure (HFrEF) N=12
Receives: Biological: Infusion of 3-OHB; Biological: Infusion of placebo
HFrEF - Right heart catheterization study 2ExperimentalDose finding study (increasing dosage of 3-OHB)
Receives: Biological: Infusion of 3-OHB; Biological: Infusion of placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial efficiency

    Based on myocardial PET examinations

    Measured: 1 day

  2. Cardiac output

    Right sided heart catheterization

    Measured: 1 day

Secondary outcomes (4)

  1. Myocardial perfusion

    Based on myocardial PET examinations

    Measured: 1 day

  2. Myocardial oxygen consumption

    Based on myocardial PET examinations

    Measured: 1 day

  3. Pulmonary and wedge pressure

    Right sided heart catheterization

    Measured: 1 day

  4. Mixed venous saturation

    Right sided heart catheterization

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2017
  2. Study start17 Mar 2017
  3. Primary completion16 Nov 2017
  4. Study completion16 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized dobbel-blinded crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03073356
Sponsor's protocol ID
1-10-72-316-16
Status last verified
Jan 2017
First submitted
20 Feb 2017
Last updated
11 Dec 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Infusion of 3-OHB in people with Heart Failure, Systolic and Ketonemia, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial efficiency (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03073356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.

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