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



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:2/3/2019
Start Date:February 1, 2019
End Date:July 1, 2019
Contact:Henry A Punzi, MD
Email:punzimedcenter@aol.com
Phone:972-478-7700

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

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)

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.
We found this trial at
1
site
Carrollton, Texas 75006
Phone: 972-478-7700
?
mi
from
Carrollton, TX
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