Clinical trial NCT05644769: Chymase Angiotensin-(1-12) Axis In Hypertensive Disease
Official title: The Chymase Angiotensin-(1-12) Axis in Hypertensive Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Trinity Hypertension & Metabolic Research Institute
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2022-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

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Primary outcomes:
measure: Presence of human sequence of Ang-(1-12) in plasma ten untreated essential hypertensive subjects at baseline
timeFrame: At baseline
Secondary outcomes:
measure: Presence of human sequence of Ang-(1-12) in plasma of ten subjects on four weeks of treatment on Lisinopril 40 mg every day
timeFrame: Four weeks
Other outcomes:
Locations:
city: Carrollton
country: United States
facility: Punzi Medical Center
state: Texas
Study officials:
affiliation: Trinity Hypertension & Metabolic Researach Institute
name: Henry Punzi, MD
role: PRINCIPAL_INVESTIGATOR
References: