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Hormone Therapy
Angiotensin-(1-7) for Cardiovascular Health in Aging
Phase < 1
Recruiting
Led By Amy C Arnold, PhD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 65-80 years
Normotensive defined as seated blood pressure <130/80 mmHg and without hypertensive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 110 minutes
Awards & highlights
Study Summary
This trial will test whether angiotensin-(1-7), a hormone that protects against the renin-angiotensin system, can reduce the risk of cardiovascular disease in older adults by reducing sympathetic outflow and blood pressure and improving endothelial function.
Who is the study for?
This trial is for healthy older adults aged 65-80 with normal blood pressure and BMI between 18.5 and 30 kg/m2. Participants must be fluent in English, able to consent, not on certain medications or have conditions like impaired liver/renal function, anemia, diabetes, serious cardiovascular or cerebrovascular disease.Check my eligibility
What is being tested?
The study investigates if angiotensin-(1-7), a hormone that could help the heart and blood vessels work better, can lower sympathetic nervous system activity and improve blood vessel function in aging individuals compared to saline (a placebo).See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions similar to those seen with ACE inhibitors or angiotensin receptor blockers since these drugs also increase angiotensin-(1-7) levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 65 and 80 years old.
Select...
My blood pressure is below 130/80 mmHg without medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 110 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~110 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 Muscle Sympathetic Nerve Burst Rate
Secondary outcome measures
Change in Brachial Artery Diameter
Change in Heart Rate
Change in Heart Rate Variability
+5 moreOther outcome measures
Change in Aldosterone
Change in Angiotensin II
Change in Angiotensin-(1-7)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Angiotensin-(1-7)Experimental Treatment1 Intervention
Participants will receive intravenous angiotensin-(1-7) at one study visit for 110 minutes. Angiotensin-(1-7) will be given in escalating doses of 2 ng/kg/min, 4 ng/kg/min, and 8 ng/kg/min. Each of these doses will be infused for 10 minutes. Following the dose escalation, angiotensin-(1-7) will be given at 8 ng/kg/min for an additional 80 minutes. Infusion rates will be calculated for each participant based on body mass.
Group II: SalinePlacebo Group1 Intervention
Participants will receive intravenous saline at one study visit for 110 minutes total. The volume of saline will match the volume of angiotensin-(1-7) infused. Infusion rates will be calculated for each participant based on body mass.
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?
Milton S. Hershey Medical CenterLead Sponsor
495 Previous Clinical Trials
2,798,848 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,841 Previous Clinical Trials
47,814,079 Total Patients Enrolled
6 Trials studying Aging
3,384 Patients Enrolled for Aging
Amy C Arnold, PhDPrincipal InvestigatorPenn State Medical Center
2 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have difficulty making decisions due to a mental condition.I have a history of immune or blood disorders.I am taking medication that affects my nervous system.I have diabetes (type I or II) indicated by high fasting glucose or I'm on diabetes medication.I am between 65 and 80 years old.I have been on steroids for more than a week in the last month.I am younger than 65 or older than 80.My gender or ethnicity does not limit my participation.I have anemia.I have high blood pressure or a serious heart or brain blood vessel condition.I understand the study and can agree to participate.I am allergic to or cannot take certain blood pressure medicines.I am currently taking blood thinners like warfarin.My blood pressure is below 130/80 mmHg without medication.My liver tests (AST or ALT) are more than twice the normal limit.My kidney function is impaired with a creatinine level over 2.0 mg/dl.I am not pregnant, nursing, or on hormone replacement therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Angiotensin-(1-7)
- Group 2: Saline
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.
Is the age range of participants in this investigation limited to those over 25?
"To be eligible for this trial, participants must fall within the age bracket of 65-80 years old. There are 1 trials in existence specifically catered to younger individuals and 239 targeting those over 65."
Answered by AI
How many participants are being treated as part of this clinical trial?
"Indeed, records on clinicaltrials.gov demonstrate that since October 5th 2022 this study has been in the process of recruitment. In total 26 individuals from one medical center are needed for this trial which was last renewed on December 1st 2022."
Answered by AI
Does this study have room for more participants currently?
"Confirmed; as stated on clinicaltrials.gov, this trial is presently looking for participants. The study was initially publicized on October 5th 2022 and has undergone a recent update on December 1st 2022."
Answered by AI
Can I register and participate in this experiment?
"This research requires 26 volunteers who are 65 to 80 years old. Furthermore, applicants must be of any race or gender, able to provide informed consent, conversant in English language skills, possess a BMI between 18.5 and 30kg/m2, have normal blood pressure (without needing medications), and pass the history and physical exam."
Answered by AI
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