Cardiovascular DiseaseNCT03826745
The CHYMASE Angiotensin-(1-12) Axis in Cardiovascular Disease
An observational study of Cardiovascular Disease, run by Trinity Hypertension & Metabolic Research Institute at 1 site in United States.
Trial summary
Study is to evaluate the Chymase Angiotensin-(1-12) in cardiovascular disease Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Plasma/Urine
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Punzi Medical Center
Carrollton, Texas, 75006
Henry A Punzi, MD, 972-478-7700, punzimedcenter@aol.com
Kathy Cassidy, RN, 972-478-7700, clinicalresearch@punzimedicalcenter.com
About this study
Study is to evaluate the Chymase Angiotensin-(1-12) in cardiovascular disease
Read the 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)
- Conditions
- Cardiovascular Disease
- Being tested
- Plasma/Urine
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma/UrineOther
Plasma of normal male and female normotensive, hypertensive, and/or resistant hypertensive subjects.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Ang-(1-12) in Human Plasma/Urine
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start11 Feb 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trinity Hypertension & Metabolic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University
- Responsible party
- Principal investigator, Henry Anthony Punzi, Trinity Hypertension & Metabolic Research Institute
- Investigators
- Henry A Punzi, MD, Principal investigator, Punzi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826745
- Sponsor's protocol ID
- PMC-60-009
- Status last verified
- Sep 2019
- First submitted
- 30 Jan 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHYMASE Angiotensin-(1-12) Axis in Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03826745
- Acronym / sponsor ID
- PMC-60-009
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Trinity Hypertension & Metabolic Research InstituteUniversity, hospital or other
- Collaborators
- Wake Forest University
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is to evaluate the Chymase Angiotensin-(1-12) in cardiovascular disease
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma/UrinePlasma of normal male and female normotensive, hypertensive, and/or resistant hypertensive subjects. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry A Punzi, MD principal investigator
Punzi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Trinity Hypertension & Metabolic Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henry A Punzi, MD (972-478-7700, punzimedcenter@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Ang-(1-12) in Human Plasma/Urine (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.