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

Hypertension Clinical Trial

Official title:

The Chymase Angiotensin-(1-12) Axis in Hypertensive Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644769
• Other study ID #: PMC-64-0010
• Status: Recruiting
• Phase: Phase 4
• Start date: November 15, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2022
• Source: Trinity Hypertension & Metabolic Research Institute
• Contact: Henry Punzi, MD
• Phone: 972-478-7700
• Email: punzimedcenter[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	Punzi Medical Center	Carrollton	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Trinity Hypertension & Metabolic Research Institute	Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of human sequence of Ang-(1-12) in plasma ten untreated essential hypertensive subjects at baseline	Determine the presence of the human sequence of Ang-(1-12) in plasma of ten untreated hypertensive subjects at baseline	At baseline
Secondary	Presence of human sequence of Ang-(1-12) in plasma of ten subjects on four weeks of treatment on Lisinopril 40 mg every day	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	Four weeks