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

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ClinicalTrials.gov Identifier: NCT02129309
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : June 25, 2015
Sponsor:
Collaborators:
Wellcome Trust
University of Cambridge
Information provided by (Responsible Party):
Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE April 28, 2014
First Posted Date  ICMJE May 2, 2014
Last Update Posted Date June 25, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
  • 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. [ Time Frame: 12 months ]
  • Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02129309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2014)
Exploratory endpoints in Study 2 are systolic and diastolic blood pressure. [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures
Official Title  ICMJE Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures.
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.

Detailed Description

The purpose of this study:

To investigate the physiological role of apelin in the cardiovascular system in patients with COPD with raised pulmonary artery pressures.

Study Aim and hypotheses:

The primary objective is to test the above hypotheses using forearm blood flow and systemic infusions of apelin peptides.

Hypotheses:

  1. Apelin agonists are vasodilators in human resistance vessels and this effect will be altered in patients with pulmonary hypertension.
  2. Apelin peptides improve right ventricular and pulmonary haemodynamics in patients with elevated pulmonary artery pressures.

Study 1a - A validation dose study of 3 apelin agonists performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.

Study 1b- A validation dose study of apelin receptor antagonist, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.

Study 2a - To define the haemodynamic response to apelin agonists in healthy volunteers and evaluate the response.

Study 2b - To investigate the haemodynamic response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • COPD
  • Pulmonary Hypertension
Intervention  ICMJE
  • Procedure: Forearm plethysmography
    Dose response study
  • Procedure: Haemodynamic studies
    Dose response study
    Other Names:
    • Innocor
    • Bioimpedance
    • Echocardiography
Study Arms  ICMJE
  • Experimental: Systemic Apelin infusion

    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

    Intervention: Procedure: Haemodynamic studies
  • Experimental: Apelin infusion - forearm

    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.

    Intervention: Procedure: Forearm plethysmography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2014)
72
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02129309
Other Study ID Numbers  ICMJE ALPHa-COPD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Cambridge University Hospitals NHS Foundation Trust
Collaborators  ICMJE
  • Wellcome Trust
  • University of Cambridge
Investigators  ICMJE
Principal Investigator: Dr. Joseph Cheriyan, MD Cambridge University Hospitals NHS Foundation Trust
PRS Account Cambridge University Hospitals NHS Foundation Trust
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP