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

NCT05644769 | Unknown Phase 4 FDA Drug

• 1 other identifier: PMC-64-0010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

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

ACTIVE COMPARATOR

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

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

Interventions

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

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.

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

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

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.

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

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of reading, comprehending the consent process and providing written informed consent to participate in the study
• Subject willing to comply with all study visits/procedures and be available for the duration of the study
• Male or female 40 years of age to 75 years of age
• Male and female subjects naive to anti-hypertensive medications or receiving no anti-hypertensive medication for at least 6 months prior to visit 1
• 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
• 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

Sponsors & Collaborators

• Trinity Hypertension & Metabolic Research Institute: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Punzi Medical Center

Carrollton, Texas, 75006, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Henry Punzi, MD

  Trinity Hypertension & Metabolic Researach Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry Punzi, MD

CONTACT

972-478-7700; punzimedcenter@aol.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 9, 2022
• Study Start: November 15, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)