Effects of Apelin on the Lung Circulation in Pulmonary Hypertension

Investigating the Acute Pulmonary Vascular Haemodynamic Effects of Apelin in Pulmonary Hypertension

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01457170

Enrollment

Registered

2011-10-21

Start date

2012-01-31

Completion date

2014-01-31

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Pulmonary Arterial Hypertension

Keywords

Pulmonary Hypertension, Heart Failure, Apelin, Haemodynamics, pulmonary vascular resistance, cardiac output

Brief summary

The purpose of this study is to determine the effects of Apelin on the lung circulation. The investigators hypothesise that Apelin will relax the lung blood vessels and improve the pumping ability of the heart.

Detailed description

Apelin is an endogenous peptide with physiological actions in the cardiovascular system and is abundantly expressed in the pulmonary vasculature. Pre-clinical models and preliminary clinical data indicate that Apelin deficiency may mediate or contribute to the pathogenesis of pulmonary hypertension and heart failure. Apelin causes peripheral vasodilatation and increased cardiac contractility. The investigators will determine the effects of Apelin on the pulmonary circulation in 3 groups; healthy control, people with pulmonary arterial hypertension and people with pulmonary hypertension due to heart failure. Each subject will receive both Apelin infusion and saline placebo infusion in a crossover design. The infusions will be given in a random order which the subject and the investigator will be blinded to. The investigators hypothesise that Apelin will have more marked pulmonary haemodynamic effects than that observed in the systemic circulation. Moreover, the investigators propose that Apelin will have a marked vasodilatory effect on the human pulmonary vasculature and reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension or pulmonary hypertension due to left heart disease.

Interventions

DRUGSaline (Placebo)

During right heart catheterisation, saline will be infused for 15 minutes while the subject rest and for a further 15 minutes while the subject exercises using a supine ergometer.

DRUGApelin

During right heart catheterisation, Apelin will be infused at 30, 100 and 300 nanomol/min for 5 minutes. Apelin will then be infused at 300 nanomol/min for a further 15 minutes while the subject exercises using a supine ergometer.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

PULMONARY ARTERIAL HYPERTENSION Inclusion Criteria: * Pulmonary Arterial Hypertension which is Idiopathic, Heritable, associated with connective tissue disease or associated with drugs/toxins * mean pulmonary artery pressure \>/= 25mmHg * pulmonary capillary wedge pressure \< 15 mmHg * normal/reduced cardiac output * stable * WHO functional class II - IV

Exclusion criteria

* significant left ventricular dysfunction * chronic lung disease (FEV1 \< 60% or abnormal CT) * chronic thromboembolic pulmonary hypertension HEART FAILURE Inclusion Criteria: * stable on treatment for 3 months prior to study * NYHA grade II - IV * ejection fraction \<35%, left ventricular end-diastolic diameter \> 5.5 cm and/or shortening fraction \< 20% * Tricuspid regurgitant velocity \>/= 3.0 m/s HEALTHY VOLUNTEERS Inclusion Criteria: * mean pulmonary artery pressure \< 25 mmHg * tricuspid regurgitant velocity \< 2.5 m/s

Design outcomes

Primary

Measure	Time frame	Description
Change in pulmonary vascular resistance	5,10,15 and 30 minutes after start of infusion	We will measure the change in pulmonary vascular resistance after infusion of Apelin during right heart catheterisation

Secondary

Measure	Time frame	Description
Change in systemic vascular resistance	5,10,15 and 30 minutes after start of infusion	We will measure the change in systemic vascular resistance during infusion of Apelin
Change in Cardiac Output	5,10,15 and 30 minutes after start of infusion	We will measure the change in cardiac output after infusion of Apelin during right heart catheterisation.

Countries

United Kingdom

Contacts

Primary ContactAndrew J Peacock, BSc MPhil MD

apeacock@udcf.gla.ac.uk+44 (0)141 951 5497

Backup ContactLauren Brash, MBChB

laurenbrash@nhs.net+44 (0)7738569980

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026