NCT02315001

Brief Summary

A single-centre double-blind placebo-controlled crossover randomised controlled trial to determine the physiological basis of glucagon-like peptide-1 receptor activation on exercise haemodynamics, as manifest through specific electrophysiological parameters measured by serial exercise stress testing, in those patients with reversible myocardial ischaemia and obstructive coronary artery disease confirmed by a baseline exercise test and coronary angiography respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2014

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

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

November 10, 2014

Last Update Submit

May 19, 2015

Conditions

Ischaemic Heart DiseaseCoronary Heart DiseaseChronic Stable Angina

Keywords

LiraglutideGLP-1Ischaemic heart diseaseCoronary heart diseaseChronic stable angina

Outcome Measures

Primary Outcomes (2)

  • Change in rate pressure product at 0.1 mV ST-segment depression

    Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

  • Change in degree of ST-segment depression at peak exercise

    Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

Secondary Outcomes (7)

  • Change in total exercise duration

    Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

  • Change in time to 0.1 mV ST-segment depression

    Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

  • Change in recovery time to 0.05 mV ST-segment depression

    Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

  • Evidence of hypoglycaemia

    During 6-week study protocol

  • Evidence of renal dysfunction

    During 6-week study protocol

  • +2 more secondary outcomes

Study Arms (2)

Liraglutide

ACTIVE COMPARATOR

Week 1 Run-In Phase = 0.6 mg (0.1 ml) Liraglutide once daily via subcutaneous injection Week 2 Low-Dose Phase = 1.2 mg (0.2 ml) Liraglutide once daily via subcutaneous injection Week 3 High-Dose Phase = 1.8 mg (0.3 ml) Liraglutide once daily via subcutaneous injection

Drug: Liraglutide

Saline Placebo

PLACEBO COMPARATOR

Week 1 Run-In Phase = 0.1 ml normal saline once daily via subcutaneous injection Week 2 Low-Dose Phase = 0.2 ml normal saline once daily via subcutaneous injection Week 3 High-Dose Phase = 0.3 ml normal saline once daily via subcutaneous injection

Other: Placebo

Interventions

LiraglutideDRUG

GLP-1 receptor agonist administered via subcutaneous injection

Also known as: Victoza
Liraglutide
PlaceboOTHER

Volume-matched normal saline placebo administered via subcutaneous injection

Saline Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 18-80
  • Patients with a recent abnormal exercise tolerance test demonstrating \>0.1 mV of planar or down-sloping ST-segment depression.
  • Patients with known coronary artery disease and angiographic evidence of a \>70% stenosis in a main epicardial artery, with or without coronary stenoses elsewhere.
  • Patients must be able to walk confidently on a treadmill.
  • Patients must have a normal resting electrocardiogram (ECG) in sinus rhythm without bundle branch aberration or other conduction disturbance.
  • Patients must have normal left ventricular function.

You may not qualify if:

  • An abnormal resting ECG including atrial fibrillation, bundle branch aberration or other conduction disturbance.
  • Pre-existing left ventricular systolic dysfunction.
  • Pre-existing ischaemic or non-ischaemic cardiomyopathy.
  • Pre-existing valvular heart disease.
  • Inability to safely negotiate an exercise treadmill.
  • Type I diabetes mellitus.
  • Type II diabetes mellitus taking oral or subcutaneous anti diabetic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, Greater London, SE17EH, United Kingdom

Location

Related Publications (2)

  • Myat A, Arri S, Bhatt DL, Gersh BJ, Redwood SR, Marber MS. Design and rationale for the randomised, double-blinded, placebo-controlled Liraglutide to Improve corONary haemodynamics during Exercise streSS (LIONESS) crossover study. Cardiovasc Diabetol. 2015 Feb 19;14:27. doi: 10.1186/s12933-015-0193-4.

    PMID: 25848859BACKGROUND

  • Myat A, Redwood SR, Arri S, Gersh BJ, Bhatt DL, Marber MS. Liraglutide to Improve corONary haemodynamics during Exercise streSS (LIONESS): a double-blind randomised placebo-controlled crossover trial. Diabetol Metab Syndr. 2021 Feb 12;13(1):17. doi: 10.1186/s13098-021-00635-6.

    PMID: 33579317DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseAngina, Stable

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Michael Marber, PhD FRCP

    King's College London

    PRINCIPAL INVESTIGATOR

  • Simon Redwood, MD FRCP

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

December 11, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

GB(1)