Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures

NCT02129309 | Completed

• 1 other identifier: ALPHa-COPD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are interested in studying how Pulmonary Hypertension occurs. A substance called 'apelin', that naturally occurs in the body has been shown to have an important role in heart disease. Previous studies have shown that it can make blood vessels get wider, and help blood flow around the body and thus improve the way the heart and lungs work. The investigators are looking to recruit both healthy and COPD pulmonary hypertension patients to study 3 types of apelin. The purpose of this study is to help the investigators understand how Pulmonary Hypertension occurs which may will help with the development of future treatments.

Conditions

COPD; Pulmonary Hypertension

Keywords

COPD; Apelin; agonist; antagonist

Outcome Measures

Primary Outcomes (2)

• Percentage change in forearm blood flow in the infused arm. Forearm blood flow ratio in each arm, blood pressure and heart rate will also be reported.

  12 months

• Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate.

  12 months

Other Outcomes (1)

• Exploratory endpoints in Study 2 are systolic and diastolic blood pressure.

  12 months

Study Arms (2)

Systemic Apelin infusion

EXPERIMENTAL

Study 2a - Haemodynamic studies to investigate the response to systemic infusions of 3 apelin agonists in healthy volunteers Study 2b - Haemodynamic studies to investigate the response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures

Procedure: Haemodynamic studies

Apelin infusion - forearm

EXPERIMENTAL

Study 1a - A validation dose study of 3 apelin agonists using forearm plethysmography to evaluate changes in forearm blood flow: performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures. Study 1b- A validation dose study of apelin receptor antagonist using forearm plethysmography to evaluate changes in forearm blood flow, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.

Procedure: Forearm plethysmography

Interventions

Forearm plethysmography PROCEDURE

Dose response study

Apelin infusion - forearm

Haemodynamic studies PROCEDURE

Dose response study

Also known as: Innocor, Bioimpedance, Echocardiography

Systemic Apelin infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Aged 18 to 70 years
• Non-smoker (\<1 cigarette per week)
• If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test COPD patients with estimated Pulmonary Artery Pressure (PAP) on echo \>25mmHg
• Clinical diagnosis of COPD as per standard criteria
• Between 18 and 70 years
• If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test

You may not qualify if:

• pre-existing:
• Systemic Hypertension (sustained BP \>160/100mmHg)
• Ischaemic Heart Disease
• Primary valvular heart disease
• Significant left ventricular failure
• Active malignancy
• Renal disease (Creatinine \>180 µmol/L)
• Neurological disease
• Diabetes mellitus
• BMI \>35, BMI \<17
• Pregnancy
• Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study.
• Current involvement in other research studies, other than observational/non-interventional
• Known HIV

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• Wellcome Trust: collaborator
• University of Cambridge: collaborator

Study Sites (1)

Vascular Research Unit, Clinical Pharmacology Unit, ACCI, Level 3, Addenbrooke's Hospital, Hills Road

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr. Joseph Cheriyan, MD

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician & Clinical Pharmacologist

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 2, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 25, 2015

Record last verified: 2015-01

Locations

GB (1)