Clinical trial

Role of Sympathetic Activity and Splanchnic Capacitance in Hypertension

Name
141218
Description
The purpose of this study is to better understand the role of the abdominal veins (splanchnic capacitance) and the sympathetic nervous system in human hypertension. The investigators will test the hypothesis that constriction of abdominal veins due to sympathetic activation contributes to human hypertension. Splanchnic capacitance will be assessed in normotensive and hypertensive subjects at baseline and during acute blockade of the autonomic nervous system.
Trial arms
Trial start
2015-04-01
Estimated PCD
2024-07-01
Trial end
2024-08-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Trimethaphan
Trimethaphan is a Nn-nicotinic receptor antagonist that blocks sympathetic and parasympathetic transmission at the level of the autonomic ganglia. It will be administered as an acute intravenous infusion with doses ranging from 0.5 to 5.0 mg/min.
Arms:
Study day with trimethaphan
Other names:
Trimethaphan Camsylate
Nitroglycerin
Sublingual nitroglycerin (0.3-0.6 mg) will be given after baseline measurements.
Arms:
Radionuclide Study day with nitroglycerin
Other names:
Nitroglycerin sublingual, nitrostat
Size
12
Primary endpoint
Splanchnic venous capacitance
after 10 minutes of autonomic blockade
Eligibility criteria
Inclusion Criteria: * Lean and obese, male and female subjects of all races between 18 and 65 years of age. * Normotensive and hypertensive subjects will be enrolled. Hypertension will be defined as a systolic BP ≥140 mm Hg and/or a diastolic BP ≥ 90 mm Hg, taken in the seated position in at least 2 separate occasions. All subjects will be otherwise normal volunteers. * Subjects able and willing to provide informed consent. Exclusion Criteria: * Pregnancy. * Subjects with morbid obesity (BMI \> 40 kg/m2). * Subjects with any chronic disease (other than hypertension) including diabetes, cardiovascular disease, history of smoking, or if they take any medication that have known effects autonomic functions, or other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing. * Current smokers or history of heavy smoking (\>2 packs/day) * Lean normotensive subjects will be excluded if they have a strong family history of hypertension (both parents treated or diagnosed), diagnosis of sleep apnea or a high score in the Berlin questionnaire for sleep apnea, or if they are highly trained athletes.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}
Updated at
2023-09-05

1 organization

2 products

1 indication

Indication
Hypertension