NCT02245230TerminatedPhase 1
Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension
Source: ClinicalTrials.gov · Last updated 9 Jan 2024
Reason given: We were not able to enroll adequate number of participants that met the inclusion/exclusion criteria, and we run out of funding.
Brief summary (registry, in English)
The purpose of this study is to better understand the cardiovascular effects of the vasodilatory peptide Angiotensin (1-7) in human hypertension. In this study, the investigators will test the hypothesis that systemic Angiotensin (1-7) infusion produces negligible effects with intact baroreceptors, and that the cardiovascular effects of this peptide are unmasked following elimination of baroreflex buffering.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 17 Sept 2014
- Start date
- Jan 2015
- Primary completion date
- Dec 2023
- Lead sponsor
- Vanderbilt University
- Diseases
- High blood pressure
- NCT number
- NCT02245230
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allergic reaction to study medications
- Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy
- Treatment with phosphodiesterase 5 inhibitors
- Treatment with anticoagulants
- Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
- Treatment with any investigational drug in the 1 month preceding the study
Other illness
- Current smokers or history of heavy smoking (>2 packs/day)
- History of alcohol or drug abuse
- History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- History or presence of immunological or hematological disorders
Lab values
- Evidence of type I or type II diabetes (i.e. fasting glucose >126 mg/dl, use of anti-diabetic medications)
- Impaired hepatic function [aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) > 2.0 x upper limit of normal range]
- Impaired renal function (serum creatinine >1.5 mg/dl)
- Anemia (hemoglobin <13.5 g/dl in males or <12.5 g/dl in females)
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e. clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol)
Other
- Pregnancy or breast feeding
- Inability to give, or withdraw, informed consent
Who the study is looking for
- Males and females of all races between 18 and 60 years of age
- Hypertension defined by two or more properly measured seated blood pressure readings >130/85 mmHg. This will allow us to include subjects with "pre-hypertension."
- Able and willing to provide informed consent
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.