The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Hypertensive Versus Healthy Subjects

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate how the effect of infused sodium nitrite differs in hypertensives compared to healthy age and sex matched controls. The effects on renal handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central blood pressure will be evaluated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Erling Bjerregaard Pedersen

Criteria

Inclusion Criteria (subjects with hypertension):

• BMI 18.5-30.0

• Ambulatory daytime blood pressure >135 mmHg systolic and/or >85 mmHg diastolic

• Women of childbearing potential must use safe contraception

Exclusion Criteria (subjects with hypertension):

• Tobacco smoking, medicine or substance abuse

• Weekly consumption of more than 14 units (12 g alcohol per unit) for women and 21 units for men

• Pregnancy or nursing

• Neoplasia

• Clinically significant heart, lung, liver, kidney, metabolic or neurologic disease

• Albuminuria > 300 mg/L

• Renography with signs of renal artery stenosis or hydronephrosis

• Clinically signs of secondary hypertension

• Clinically significant hypokalemia

• Clinically significant anemia

• Estimated glomerular filtration rate (eGFR) < 60 ml/min

• Clinically significant findings in screening blood samples, urine sample or ECG

• Persistent office blood pressure > 170/105 mmHg on the maximum dose of amlodipine (10 mg daily)

• Unacceptable symptoms of elevated blood pressure

• Unacceptable side effects of amlodipine

Inclusion Criteria (healthy normotensive subjects):

• BMI 18.5-30.0

• Women of childbearing potential must use safe contraception

Exclusion Criteria (healthy normotensive subjects):

• Tobacco smoking, medicine or substance abuse

• Weekly consumption of more than 14 units (12 g alcohol per unit) for women and 21 units for men

• Medical treatment 2 weeks prior to each examination day, except for contraception

• Pregnancy or nursing

• Neoplasia

• Clinically significant heart, lung, liver, kidney, metabolic or neurologic disease

• Clinically significant albuminuria

• Clinically significant anemia

• Estimated glomerular filtration rate (eGFR) < 60 ml/min

• Clinically significant findings in screening blood samples, urine sample or ECG

• Ambulatory daytime blood pressure >135/85 mmHg

• Blood donation within 1 month of the first examination day