RightFit
RecruitingEarly Phase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Procedures mentioned: Infusions, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This is an outpatient study that requires a screening visit, and if eligible, two study visits separated by at least one week in the Clinical Research Center within the Penn State Milton S."
  • "The study visits will include intravenous infusion of angiotensin-(1-7) or saline for approximately two hours, starting with increasing doses and holding at a steady-state dose."
  • "Endothelial function will be measured and blood samples collected at baseline and at the end of infusion."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an experimental drug called angiotensin-(1-7) can improve heart and blood vessel health. It is for adults ages 18 to 65 with obesity and blood pressure that is above normal.

Obesity is a global health concern that is associated with high blood pressure and an increased risk for developing cardiovascular disease. The purpose of this study is to find out if the investigational drug angiotensin-(1-7) can improve cardiovascular health in people with obesity and high blood pressure.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men and women of all races, ages 18 to 65.
  • Body mass index (BMI), a measure of weight compared with height, from 30 to 45.
  • At least two blood pressure readings above 120/80 while seated, or use of medicine for high blood pressure.
  • Able to understand the study and agree to take part.
  • Able to read and speak English fluently.
  • Health history and physical exam meet the study's requirements.

Who can't join

  • Taking more than two blood pressure medicines, or having high blood pressure caused by another medical condition.
  • Pregnant or breastfeeding, or a woman who has used hormone replacement therapy within 6 months.
  • Unable to understand or give consent, withdrawing consent, or being a prisoner.
  • Alcohol or drug abuse, current smoking, being a highly trained athlete, or a weight change of more than 5% in the past 3 months.
  • Type 1 or type 2 diabetes, including fasting blood sugar above 126 mg/dL or use of diabetes medicine.
  • A history of serious heart or blood vessel disease, stroke, bleeding in the brain, or a mini-stroke.
  • Immune system or blood disorders; anemia (too few healthy red blood cells); liver tests above twice the normal limit; or a kidney blood test called creatinine above 2.0 mg/dL.
  • Use of stimulants or certain medicines that increase nerve activity; PDE-5 inhibitors; blood thinners such as warfarin; steroid medicines that affect the whole body for more than 7 days in a row in one month; or any experimental drug in the month before the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Men and women of all races * Age 18 to 65 years * Body mass index (BMI) between 30-45 kg/m2 * Pre-hypertension (defined as two or more seated blood pressure readings \>120/80 mmHg) or 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 ≥ 66 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 * BMI \> 45 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

Study sites (1)

PA