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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01457170
Date of registration: 20/10/2011
Prospective Registration: Yes
Primary sponsor: Golden Jubilee National Hospital
Public title: Effects of Apelin on the Lung Circulation in Pulmonary Hypertension
Scientific title: Investigating the Acute Pulmonary Vascular Haemodynamic Effects of Apelin in Pulmonary Hypertension
Date of first enrolment: January 2012
Target sample size: 63
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01457170
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
United Kingdom
Contacts
Name:     Andrew J Peacock, BSc MPhil MD
Address: 
Telephone: +44 (0)141 951 5497
Email: apeacock@udcf.gla.ac.uk
Affiliation: 
Name:     Andrew J Peacock, BSc MPhil MD
Address: 
Telephone:
Email:
Affiliation:  National Health Service: Golden Jubilee National Hospital
Key inclusion & exclusion 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

Exclusion Criteria:

- obstructive coronary artery disease

ALL SUBJECTS

Exclusion Criteria:

- bleeding diathesis

- women of childbearing potential without pregnancy test

- systolic blood pressure > 190 mmHg or < 100 mmHg

- malignant arrhythmias

- renal or hepatic failure

- haemodynamically significant valvular heart disease

- severe or significant co-morbidity

- pacemaker

- already taking part in another trial

- lack of informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Heart Failure
Pulmonary Arterial Hypertension
Intervention(s)
Drug: Apelin
Drug: Saline (Placebo)
Primary Outcome(s)
Change in pulmonary vascular resistance [Time Frame: 5,10,15 and 30 minutes after start of infusion]
Secondary Outcome(s)
Change in Cardiac Output [Time Frame: 5,10,15 and 30 minutes after start of infusion]
Change in systemic vascular resistance [Time Frame: 5,10,15 and 30 minutes after start of infusion]
Secondary ID(s)
11/CARD/04
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Imperial College Healthcare NHS Trust
NHS Lothian
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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