Recruiting

Angiotensin-(1-12)

Sponsor:

Trinity Hypertension & Metabolic Research Institute

Code:

NCT05644769

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Determine the presence of Human sequence Ang-(1-12) on no medication

Human sequence Ang-(1-12) on Lisinopril 40mg every day

Study Details

Brief summary:

Determine the presence of the human sequence of Angiotensin-(1-12) in plasma of ten untreated hypertensive subjects and after 4 week with Lisinopril 40 mg every day. Determine the blood pressure reduction with Lisinopril 40mg.

Conditions

Hypertension

Study ID

NCT05644769

Start date

Nov 15, 2022

Status verified date

Dec, 2022

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Mar 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Capable of reading, comprehending the consent process and providing written informed consent to participate in the study
2. Subject willing to comply with all study visits/procedures and be available for the duration of the study
3. Male or female 40 years of age to 75 years of age
4. Male and female subjects naive to anti-hypertensive medications or receiving no anti-hypertensive medication for at least 6 months prior to visit 1
5. Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood pressure of equal/over 90 mm Hg and equal/less 109 mm Hg and/or Systolic blood pressure equal/over 140 mm Hg and equal/less 179 mm Hg on visit 1
6. Women may be enrolled if all three of the following criteria are met:

Have a negative urine pregnancy test at visit 1, for females of childbearing potential Are not breastfeeding Do not plan to become pregnant during the study And if one of the following three criteria is met Have had a hysterectomy or tubal ligation at least six months prior to signing the informed consent form Have been postmenopausal for at least one year Are of childbearing potential and will practice one of the following methods of birth control though out the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide. Abstinence, partner's vasectomy are not acceptable methods of contraception

Exclusion Criteria:

-

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Determine the presence of the human sequence of Ang-(1-12) in plasma on no medications

Determine the presence of the human sequence of Ang-(1-2) in the plasma of ten normal male and female hypertensive patients at baseline on no medications.

active comparator: Determine the presence of human sequence of Ang-(1-12) on Lisinopril 40 mg every day

Determine the presence of the human sequence of Ang-(1-12) in the plasma of 10 normal male and female hypertensive patients at baseline and after four weeks on Lisinopril 40 mg every day

Interventions

Determine the presence of Human sequence Ang-(1-12) on no medication

Determine the presence of the human sequence of Ang-(1-12) in the plasma of ten normal male and female hypertensive patients on no medication.

Human sequence Ang-(1-12) on Lisinopril 40mg every day

Determine the presence of the human sequence of Ang-(1-12) in the plasma of 10 normal male and female hypertensive patients after four weeks on Lisinopril 40 mg every day.

Primary outcome measure

  • Presence of human sequence of Ang-(1-12) in plasma ten untreated essential hypertensive subjects at baseline [ Time Frame: At baseline ]

Central Contacts and Locations

Central contacts

Locations

Punzi Medical Center

Recruiting

Carrollton, Texas, United States, 75006

Contacts

More Information

Sponsor

Trinity Hypertension & Metabolic Research Institute

Last update posted

Dec 9, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Trinity Hypertension & Metabolic Research Institute on 2022-12-09.