Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension

Launched by MILTON S. HERSHEY MEDICAL CENTER · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a new drug called angiotensin-(1-7) might help improve heart health in people who are dealing with obesity and high blood pressure. Obesity is a growing health issue that can lead to serious problems, including heart disease. The researchers want to see if this investigational drug can make a positive difference for individuals who have a body mass index (BMI) between 30 and 40 and are experiencing high blood pressure.

To participate in the trial, you need to be between 18 and 60 years old, and you should have hypertension, which means your blood pressure is consistently higher than normal. The study is open to both men and women of all backgrounds. Participants will have regular check-ups and assessments to monitor their health during the trial. It's important to note that certain conditions, like severe obesity, diabetes, or serious heart problems, might prevent someone from taking part. If you're interested, be sure to discuss it with your healthcare provider to see if this trial might be a good fit for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women of all races
• • Age 18 to 60 years
• • Body mass index (BMI) between 30-40 kg/m2
• • Hypertension defined as two or more seated blood pressure readings \>130/80 mmHg or use of antihypertensive medications
• • Capable of giving informed consent
• • Fluent in written and spoken English
• • Satisfactory history and physical exam
• Exclusion Criteria:
• • Age ≤ 17 or ≥ 61 years
• • Taking more than two antihypertensive medications
• • Secondary causes of hypertension (e.g., pheochromocytoma, primary aldosteronism, aortic coarctation, adrenal disease)
• • Pregnant or nursing women
• • Women taking hormone replacement therapy within 6 months
• • Decisional impairment
• • Prisoners
• • Alcohol or drug abuse
• • Current smokers
• • Highly trained athletes
• • Subjects with \>5% weight change in the past 3 months
• • Morbid obesity (BMI \> 40 kg/m2)
• • Evidence of type I or type II diabetes (fasting glucose \> 126 mg/dL or use of anti-diabetic medications)
• • History of serious cardiovascular disease (e.g. myocardial infarction within 6 months, symptomatic coronary artery disease, presence of angina pectoris, significant arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy) or cerebrovascular disease (e.g. cerebral hemorrhage, stroke, transient Ischemic attack)
• • History or presence of immunological or hematological disorders
• • Impaired hepatic function \[aspartate aminotransferase (AST) or alanine transaminase (ALT) levels \>2 times upper limit of normal range\]
• • Impaired renal function (serum creatinine \>2.0 mg/dl)
• • Anemia
• • Treatment with drugs increasing sympathetic activity \[e.g., serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors, stimulants\]
• • Treatment with phosphodiesterase-5 inhibitors
• • Treatment with anticoagulants (e.g. warfarin)
• • Treatment with chronic systemic glucocorticoid therapy (\>7 consecutive days in 1 month)
• • Treatment with any investigational drug in the 1-month preceding the study
• • Inability to give, or withdraw, informed consent