Chymase Angiotensin-(1-12) Axis In Hypertensive Disease

Phase 4

Recruiting

• Conditions: Hypertension
• Interventions: Other: Determine the presence of Human sequence Ang-(1-12) on no medication; Drug: Human sequence Ang-(1-12) on Lisinopril 40mg every day

• Registration Number: NCT05644769
• Lead Sponsor: Trinity Hypertension & Metabolic Research Institute

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.

Detailed Description

Determine the presence of the human sequence of Ang-(1-12) in the plasma of ten normal male and female hypertensive patients at baseline and after 4 weeks on Lisinopril 40mg every day. Measure concentrations of Ang-(1-12) in either spot urine collections from ten male and female hypertensive patients at baseline and after 4 weeks of Lisinopril 40mg every day.

Study Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2022-11-22
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Determine the presence of the human sequence of Ang-(1-12) in plasma on no medications	Determine the presence of Human sequence Ang-(1-12) on no medication	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.
Determine the presence of human sequence of Ang-(1-12) on Lisinopril 40 mg every day	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 at baseline and after four weeks on Lisinopril 40 mg every day

Primary Outcome Measures

Name	Time	Method
Presence of human sequence of Ang-(1-12) in plasma ten untreated essential hypertensive subjects at baseline	At baseline	Determine the presence of the human sequence of Ang-(1-12) in plasma of ten untreated hypertensive subjects at baseline

Secondary Outcome Measures

Name	Time	Method
Presence of human sequence of Ang-(1-12) in plasma of ten subjects on four weeks of treatment on Lisinopril 40 mg every day	Four weeks	Determine the presence of the human sequence of Ang-(1-12) in the plasma of ten normal male and female hypertensive patients after four weeks on Lisinopril 40 mg every day

Trial Locations

Locations (1)

Punzi Medical Center; 🇺🇸 Carrollton, Texas, United States