NCT03073356

Brief 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. Myocardial efficiency and hemodynamics will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

March 17, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed
Last Updated

December 11, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

February 20, 2017

Last Update Submit

December 8, 2017

Conditions

Heart Failure, SystolicKetonemia

Keywords

Myocardial metabolismPositron emission tomographyEchocardiographyRight sided heart catheterization

Outcome Measures

Primary Outcomes (2)

  • Myocardial efficiency

    Based on myocardial PET examinations

    1 day

  • Cardiac output

    Right sided heart catheterization

    1 day

Secondary Outcomes (4)

  • Myocardial perfusion

    1 day

  • Myocardial oxygen consumption

    1 day

  • Pulmonary and wedge pressure

    1 day

  • Mixed venous saturation

    1 day

Study Arms (4)

Control - Healthy test subjects

EXPERIMENTAL

Age matched subjects without symptoms of heart failure or ischemic heart disease N=10

Biological: Infusion of 3-OHBBiological: Infusion of placebo

HFrEF - Heart failure patients investigated by PET

EXPERIMENTAL

Patients with heart failure (HFrEF) N=12

Biological: Infusion of 3-OHBBiological: Infusion of placebo

HFrEF - Right heart catheterization

EXPERIMENTAL

Patients with heart failure (HFrEF) N=12

Biological: Infusion of 3-OHBBiological: Infusion of placebo

HFrEF - Right heart catheterization study 2

EXPERIMENTAL

Dose finding study (increasing dosage of 3-OHB)

Biological: Infusion of 3-OHBBiological: Infusion of placebo

Interventions

Infusion of 3-OHBBIOLOGICAL

Increase in 3-OHB levels

Also known as: Na-3-OHB
Control - Healthy test subjectsHFrEF - Heart failure patients investigated by PETHFrEF - Right heart catheterizationHFrEF - Right heart catheterization study 2
Infusion of placeboBIOLOGICAL

NaCl

Also known as: NaCl
Control - Healthy test subjectsHFrEF - Heart failure patients investigated by PETHFrEF - Right heart catheterizationHFrEF - Right heart catheterization study 2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of cardiology, Aarhus university hospital Skejby

Aarhus, Central Jutland, 8200, Denmark

Location

MeSH Terms

Conditions

Heart Failure, SystolicKetosis

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular DiseasesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Roni R Nielsen, MD PHD

    Dept. of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized dobbel-blinded crossover
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 8, 2017

Study Start

March 17, 2017

Primary Completion

November 16, 2017

Study Completion

November 16, 2017

Last Updated

December 11, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)