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Peptide
Angiotensin 1-7 for Obesity Hypertension
Phase < 1
Recruiting
Led By Amy C Arnold, Ph.D.
Research Sponsored by Amy Arnold
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hypertension defined as two or more seated blood pressure readings >130/80 mmHg or use of anti-hypertensive medications
Age 18-60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study Summary
This trial will test if angiotensin-(1-7) can help improve cardiovascular health for people with obesity and high blood pressure.
Who is the study for?
This trial is for adults aged 18-60 with obesity (BMI of 30-40) and high blood pressure, who can consent to participate. It's not for smokers, athletes, those with diabetes or serious heart conditions, pregnant women, or people on certain medications like anticoagulants and SNRIs.Check my eligibility
What is being tested?
The study tests whether angiotensin-(1-7), a new drug candidate, can improve heart health in obese patients with hypertension compared to saline (a placebo). Participants will receive either the drug or placebo to assess its effectiveness.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions typical of cardiovascular drugs such as dizziness, headache, changes in blood pressure or electrolyte imbalances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high blood pressure or am taking medication for it.
Select...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in brachial artery diameter with reactive hyperemia
Secondary outcome measures
Change in coronary blood velocity to the cold pressor test
Change in muscle sympathetic nerve activity to the cold pressor test
Change in systolic and diastolic blood pressure to the cold pressor test
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Angiotensin-(1-7)Experimental Treatment1 Intervention
Participants receive intravenous angiotensin-(1-7) at one study visit for 100 minutes total. Angiotensin-(1-7) will be given in escalating doses of 2ng/kg/min, 4ng/kg/min, and 8ng/kg/min. Each of these doses will be infused for 10 minutes. Following the dose escalation, angiotensin-(1-7) will be given at 8ng/kg/min for an additional 70 minutes. Infusion rates will be calculated for each patient based on body mass.
Group II: SalinePlacebo Group1 Intervention
Participants receive intravenous saline at one study visit for 100 minutes total. The volume of saline will match the volume of angiotensin-(1-7) infused. Infusion rates will be calculated for each patient based on body mass. Saline will be given in escalating doses for 10 minutes each and then held for 70 minutes at the highest dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin-(1-7)
2020
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,602 Total Patients Enrolled
Amy ArnoldLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Amy C Arnold, Ph.D.Principal InvestigatorPenn State College of Medicine
1 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver tests (AST or ALT) are more than twice the normal limit.I have anemia.I have difficulty making decisions due to a mental condition.I am currently taking blood thinners like warfarin.I have been on steroids for more than a week in the past month.I am unable to understand or decide about participating in this study.You have gained or lost more than 5% of your body weight in the last 3 months.I have had serious heart or stroke-related health issues recently.I have a history of immune or blood disorders.I have high blood pressure or am taking medication for it.I am a person of any gender or race.Your body mass index (BMI) is between 30 and 40.I understand the study and can agree to participate.I am either 17 years old or younger, or 61 years old or older.I am taking medication for erectile dysfunction.You have problems with drinking too much alcohol or using drugs.I am between 18 and 60 years old.You are currently smoking.People who are professional athletes.I have diabetes (type I or II) indicated by high fasting glucose or I'm on diabetes medication.My kidney function is impaired with high creatinine levels.I am currently taking medication for depression or anxiety.
Research Study Groups:
This trial has the following groups:- Group 1: Saline
- Group 2: Angiotensin-(1-7)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include participants of advanced age?
"To join this trial, patients must be aged 18 to 60. Those younger than 18 have 267 other studies to consider and individuals above 65 can access 1,331 different trials."
Answered by AI
What is the cap for enrollees in this research project?
"That is correct. Data from clinicaltrials.gov confirms that this medical study, which was first posted on April 1st 2019, is actively searching for individuals to participate in the trial. Approximatley 24 people are needed across a single site."
Answered by AI
Has Angiotensin-(1-7) been explored as part of any other exploratory treatments?
"Currently, 121 clinical trials are underway to assess the efficacy of Angiotensin-(1-7), with 31 being in Phase 3. 798 facilities across the world have been chosen as sites for these studies, though most reside in Calgary, Alberta."
Answered by AI
What medical conditions can Angiotensin-(1-7) be utilized to treat?
"Angiotensin-(1-7) can be used to reduce hemodilution, as well as treat certain states of hypokalemia and dehydration necessitating oral hydration therapy."
Answered by AI
Is enrollment for this clinical experiment currently open?
"Indeed, the details posted on clinicaltrials.gov confirm that this medical research project is currently searching for 24 individuals from one location. It was initially published in April 2019 and most recently updated in December 2022."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Penn State College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Penn State College of Medicine: < 48 hours
Typically responds via
Email
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