The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects

What Was Tested

This registered phase 1 trial tested Apelin.

The purpose of this study is to * Determine blood peptide levels and investigate any tissue gradients of apelin in patients with idiopathic pulmonary arterial hypertension and healthy volunteers. * Evaluate the effect of exogenous apelin infusion on exercise performance in healthy volunteers and patients with idiopathic pulmonary arterial hypertension.

It had two arms (groups): Apelin (experimental) and Control (placebo comparator).

Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously.

Subject will take cardiopulmonary exercise testing with receive placebo.

The registry classes the interventions as drug.

More on the Plan

Idiopathic pulmonary arterial hypertension remains an enigma for physician in both diagnosis and treatment.

Existing biomarkers, tissue characteristics and definite treatment are restricted.

A comprehensive characterise circulating peptide levels and investigate any tissue gradients of apelin in patients with idiopathic pulmonary arterial hypertension and healthy volunteers might provide important information about pathophysiologic process and diagnostic marker.

In addition, first time human study to assessment the effect of exogenous apelin infusion on exercise performance in healthy volunteers and patients with idiopathic pulmonary arterial hypertension is essential to confirm whether the relevance between animal models and clinical subjects.

Who Took Part

12 planned participants were the target.

It was open to men only aged from 18 years up to 90 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Structurally normal heart by 2D Echocardiography. Pulmonary artery pressure \< 25mmHg. Tricuspid velocity \< 2.5ms-1. Able to give informed consent.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: bleeding diathesis (pt \> 14 sec to aptt \> 40 sec); pregnancy, or women of child bearing potential not on adequate contraception; renal or hepatic failure.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Apelin and the comparison in turn, acting as their own control.

As a double-blind Apelin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2012-03 with completion listed for 2014-09.

It ran at 2 sites in United Kingdom (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Apelin in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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