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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Determine the presence of Human sequence Ang-(1-12) on no medication
Human sequence Ang-(1-12) on Lisinopril 40mg every day
Sponsored by
Trinity Hypertension & Metabolic Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: -

Sites / Locations

  • Punzi Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

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

Arm Description

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2022
Last Updated
December 6, 2022
Sponsor
Trinity Hypertension & Metabolic Research Institute
Collaborators
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05644769
Brief Title
Chymase Angiotensin-(1-12) Axis In Hypertensive Disease
Official Title
The Chymase Angiotensin-(1-12) Axis in Hypertensive Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trinity Hypertension & Metabolic Research Institute
Collaborators
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Determine the presence of the human sequence of Ang-(1-12) in plasma on no medications
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Determine the presence of human sequence of Ang-(1-12) on Lisinopril 40 mg every day
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Determine the presence of Human sequence Ang-(1-12) on no medication
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Human sequence Ang-(1-12) on Lisinopril 40mg every day
Intervention Description
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 Information:
Title
Presence of human sequence of Ang-(1-12) in plasma ten untreated essential hypertensive subjects at baseline
Description
Determine the presence of the human sequence of Ang-(1-12) in plasma of ten untreated hypertensive subjects at baseline
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Presence of human sequence of Ang-(1-12) in plasma of ten subjects on four weeks of treatment on Lisinopril 40 mg every day
Description
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
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henry Punzi, MD
Phone
972-478-7700
Email
punzimedcenter@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Punzi, MD
Organizational Affiliation
Trinity Hypertension & Metabolic Researach Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Punzi Medical Center
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Punzi, MD
Phone
972-478-7700
Email
punzimedcenter@aol.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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