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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cambridge, 영국, CB2 0QQ
- Vascular Research Unit, Clinical Pharmacology Unit, ACCI, Level 3, Addenbrooke's Hospital, Hills Road
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
다른 이름들:
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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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.
기간: 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.
기간: 12 months
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12 months
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기타 결과 측정
결과 측정 |
기간 |
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Exploratory endpoints in Study 2 are systolic and diastolic blood pressure.
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dr. Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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폐 고혈압에 대한 임상 시험
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University of Colorado, Denver모집하지 않고 적극적으로단심실 | 폐 혈관 저항 이상 | 대사체학 | 우수한 Cavo-Pulmonary 문합 | 엔도텔린미국