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The CHYMASE Angiotensin-(1-12) Axis in Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826745
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Wake Forest University
Information provided by (Responsible Party):
Henry Anthony Punzi, Trinity Hypertension & Metabolic Research Institute

Brief Summary:
Study is to evaluate the Chymase Angiotensin-(1-12) in cardiovascular disease

Condition or disease Intervention/treatment
Cardiovascular Disease Other: Plasma/Urine

Detailed Description:

Study is to determine the presence of the human sequence on Ang-(1-12) in the plasma of normal male and female normotensive, hypertensive and/or resistant hypertensive subjects.

To measure concentrations of Ang-(1-12) in either serum or spot urine collections from male and female normal, hypertensive and/or resistant hypertensive subjects.

To assess whether chymase activity can be detected in human serum and urine using the radiolabeled amino acid sequence of 1251-Ang-(1-12)

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CHYMASE Angiotensin-(1-12) Axis in Cardiovascular Disease
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Plasma/Urine
    Plasma of normal male and female normotensive, hypertensive, and/or resistant hypertensive subjects.


Primary Outcome Measures :
  1. Presence of Ang-(1-12) in Human Plasma/Urine [ Time Frame: one day ]
    Determine the presence of the human sequence of Ang-(1-12) in the plasma of normal male and female normotensive, hypertensive and/or resistant hypertensive subjects.


Biospecimen Retention:   Samples Without DNA
Human Plasma and Urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
25 normotensive subjects (40-50% females) aged 40 years and above, 25 untreated or treated essential hypertensive subject (40-50%) females) age 40 years and above, and 25 subjects with diagnosis of resistant hypertension (blood pressure not controlled on 3 or more drugs) (40-50% female) aged 40 years and above.
Criteria

Inclusion Criteria:

  • Cable of reading, comprehending the consent process and providing written informed consent to participate in the study.
  • Male or female equal/over 40 years of age.
  • Currently being treated with 3 medications and are not at goal seated, Blood pressure of Systolic blood pressure less 140 mmHg and/or Diastolic blood pressure less 90 mmHg (Diabetic patients goal seated blood pressure- Systolic blood pressure less 130 and/or Diastolic blood pressure less 80) OR
  • Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood pressure of equal/over 90 mmHg and equal/less 115 mmHg and/or Systolic blood pressure equal/over 140 mmHg and equal/less 180 mmHg OR
  • Normotensive patients defined as a blood pressure less 140/90 mmHg
  • Women may be enrolled if all three of the following criteria are met:
  • Have a negative urine pregnancy test at screening, for females of childbearing potential
  • Are not breastfeeding
  • Do not plan t become pregnant during the study
  • And if one of the following three criteria is met:
  • Have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form
  • Have been postmenopausal for at least 1 year
  • Are of childbearing potential and will practice one of the following methods of birth control throughout 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:

  • Patients with severe hypertension (mean seated cuff Diastolic blood pressure over 115 mmHg or mean seated Systolic blood pressure over 180 mmHg) or any form of secondary hypertension at time of screening.
  • Patients within the past 6 months with a history of hypertensive encephalopathy, stroke or transient ischemic attack.
  • Patients within the last 6 months with a history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary bypass graft, valvular surgery or unstable angina.
  • Patients with a history of heart block greater than First Degree Sino atrial Block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial Fibrillation, Atrial Flutter, Congestive Heart Failure, or other manifestations of clinically significant cardiac valvular disease.
  • Patients with hemodynamically significant cardiac valvular disease.
  • Patients with evidence of significant chronic renal impairment as indicated by a serum creatinine of over 2.5mmg/dl at Visit 1.
  • Patients with evidence of liver disease as indicated by Aspartate transaminase (Serum glutamic oxaloacetic) or Alanine aminotransferase (Serum glutamic pyruvic transaminase) over 2.5 times or total bilirubin over 1.5 times, the upper limit of the laboratory normal range at Visit 1.
  • Patients who demonstrate other laboratory test values deviating from the normal range which are considered to be clinically significant by the investigator.
  • Patients with insulin and non-insulin dependent diabetes mellitus not controlled on diet, insulin or oral hypoglycemic as defined by a Hemoglobin A1c over 10.5 % at Visit 1.
  • Severe psychological or emotional condition which may interfere with participation in the study.
  • History of or current use of illicit drugs or alcohol abuse.
  • Participation in a clinical trial and taking any investigational drug within 30 days prior to enrolling into the study (Visit 1).
  • A physical condition that would limit accurate Blood pressure measurement.
  • Any other medical condition which, in the Investigator's opinion, may render the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826745


Contacts
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Contact: Henry A Punzi, MD 972-478-7700 punzimedcenter@aol.com
Contact: Kathy Cassidy, RN 972-478-7700 clinicalresearch@punzimedicalcenter.com

Locations
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United States, Texas
Punzi Medical Center Recruiting
Carrollton, Texas, United States, 75006
Contact: Henry A Punzi, MD    972-478-7700    punzimedcenter@aol.com   
Contact: Kathy Cassidy, RN    972-478-7700    clinicalresearch@punzimedicalcenter.com   
Sponsors and Collaborators
Trinity Hypertension & Metabolic Research Institute
Wake Forest University
Investigators
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Principal Investigator: Henry A Punzi, MD Punzi Medical Center
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Responsible Party: Henry Anthony Punzi, Medical Director, Trinity Hypertension & Metabolic Research Institute
ClinicalTrials.gov Identifier: NCT03826745    
Other Study ID Numbers: PMC-60-009
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases