Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures
Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- Apelin agonists are vasodilators in human resistance vessels and this effect will be altered in patients with pulmonary hypertension.
- 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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Cambridge, Storbritannien, CB2 0QQ
- Vascular Research Unit, Clinical Pharmacology Unit, ACCI, Level 3, Addenbrooke's Hospital, Hills Road
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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 |
Dose response study
Andra namn:
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Experimentell: 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. |
Dose response study
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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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.
Tidsram: 12 months
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12 months
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Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate.
Tidsram: 12 months
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12 months
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Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
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Exploratory endpoints in Study 2 are systolic and diastolic blood pressure.
Tidsram: 12 months
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12 months
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Dr. Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ALPHa-COPD
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