Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation

University of Edinburgh

Status: Completed

Conditions: Vasodilatation; Heart Failure; Heart Disease

Treatments: Drug: Acetylcholine; Drug: Systemic apelin infusion; Drug: Sodium nitroprusside; Drug: Apelin

Study type: Interventional

Funder types: Other

Identifiers

NCT00901719

FS/09/019/26905 - 3

Details and patient eligibility

About

The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Two of the main actions of apelin are to increase the pumping ability of the heart and cause blood vessels to relax. The investigators wish to assess if these actions are altered in the setting of normal renin-angiotensin activation and increased renin-angiotensin activity.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 months to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• >18yr

Exclusion criteria

• Lack of informed consent
• Age < 18 years,
• Current involvement in other research studies,
• Systolic blood pressure >190 mmHg or <100 mmHg
• Malignant arrhythmias
• Renal or hepatic failure
• Haemodynamically significant aortic stenosis
• Severe or significant co morbidity
• Women of childbearing potential.
• Any regular medication
• Previous history of any cardiovascular disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

Sodium depletion

Experimental group

Description:

Subjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing \>2000 kcal of energy, \>60 g of protein, \<12 mmol of sodium and \<70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system.

Treatment:

Drug: Systemic apelin infusion

Drug: Apelin

Drug: Acetylcholine

Drug: Sodium nitroprusside

Normal diet

Placebo Comparator group

Description:

Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study.

Treatment:

Drug: Systemic apelin infusion

Drug: Apelin

Drug: Acetylcholine

Drug: Sodium nitroprusside