← Human Trials & Peer-Reviewed Studies

Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

Plain-language guide to NCT02490176: not phased randomized trial of Liraglutide, 50 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02490176
Phase
not phased
Status
status unknown
Start
2015-07
Completion (planned or actual)
2016-07
Participants
50 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Heart Failure
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Liraglutide.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction.

The investigators planned to evaluate the effects of liraglutide on haemodynamic parameters in patients with heart failure.

It had two arms (groups): GLP-1 group (experimental) and Control group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Heart failure (HF) is a major cause of morbidity and mortality world wide.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and has direct effects on the cardiovascular system.

However, the effects of GLP-1 on HF patients remain unclear.

Pulse indicator continuous cardiac output (PiCCO) technology is a combination of transpulmonary thermodilution and pulse contour analysis, which measures hemodynamic variables (left ventricular ejection fraction, volumes, and mass) in a fast and feasible way.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

It started in 2015-07 with completion listed for 2016-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): a change in cardiac output measured by pulse indicator continuous cardiac output (PiCCO) technology (time frame: 7 days after treatment).

It also tracked 1 secondary outcome, for example a change in left ventricular contractile index measured by PiCCO technology.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.