Liraglutide to Improve corONary Haemodynamics During Exercise streSS

Sponsor
King's College London
Study ID
NCT02315001
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Stable Angina
  • Coronary Heart Disease
  • Ischaemic Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    GLP-1 receptor agonist administered via subcutaneous injection
  • Placebo — OTHER
    Volume-matched normal saline placebo administered via subcutaneous injection

Study Details

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.

Key Dates

Start date
Jan 31, 2014
Status verified
May 2015
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Active Comparator: Liraglutide
    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
  • Placebo Comparator: Saline Placebo
    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

Primary Outcome Measure

Change in rate pressure product at 0.1 mV ST-segment depression [ Time Frame: Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol ]

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