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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02243514 |
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Date of registration:
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16/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intravascular Ultrasound Evaluation of Renal Nerves in Different Diseases
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Scientific title:
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Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02243514 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Jing Huang, MD |
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Address:
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Telephone:
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0086-13508312022 |
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Email:
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huangjing@cqmu.edu.cn |
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Affiliation:
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Name:
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Jing Huang, MD |
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Address:
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Telephone:
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0086-13508312022 |
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Email:
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huangjing@cqmu.edu.cn |
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Affiliation:
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Name:
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Jing Huang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Resistant hypertension group
- blood pressure remains above goal in spite of the concurrent use of three or
more anti-hypertensive agents(including a diuretic) at adequate doses.
- agrees to have the study procedure(s) performed and additional procedures and
evaluations
2. Essential hypertension group
- systolic blood pressure = 140 mmHg, diastolic blood pressure = 90 mmHg, or
current use of anti-hypertensive medication with a normal blood pressure or mean
ambulatory blood pressure during the 24-hour=130/80 mmHg.
- not resistant to pharmacotherapy.
- agrees to have the study procedure(s) performed and additional procedures and
evaluations
3. Chronic heart failure group
- New York Heart Association class II-III symptoms, or American College of
Cardiology(ACC) / American Heart Association(AHA) heart failure classification
B-C class of chronic heart failure.
- currently or prior have the signs of heart failure, such as elevated jugular
venous pressure, peripheral edema, pulmonary crepitations, ect.
- Systolic left ventricular dysfunction as assessed by echocardiogram with left
ventricular ejection fraction < 40%.
- agrees to have the study procedure(s) performed and additional procedures and
evaluations
4. Control group
- no history of arterial hypertension, heart failure and diabetes
- going to take a vascular interventional examination during hospitalization
- agrees to have the study procedure(s) performed and additional procedures and
evaluations
All patients have full capacity for civil conduct and agree to sign the Medical Informed
Consent.
Exclusion Criteria:
- hemodynamically or anatomically significant renal artery stenosis.
- renal artery variation.
- renal artery diameter < 4 mm, trunk length < 20 mm.
- secondary hypertension with known causes and pseudo-hypertension.
- has experienced myocardial infarction, unstable angina pectoris, or cerebrovascular
accident within 6 months.
- has an implantable cardioverter defibrillator (ICD) or pacemaker.
- requires respiratory support.
- is pregnant or planning to be pregnant.
- cardiovascular diseases with sever hemodynamic disorder.
- type 1 diabetes mellitus.
- currently enrolled in another investigational drug or device trial.
- civil disability or limited capacity for civil conduct.
- other conditions researchers considered unsuitable for enrolled in the trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Heart Failure
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Primary Outcome(s)
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Area increase of Renal nerves in patients with sympathetic over-activity diseases
[Time Frame: A duration of the whole research stage, an expected average of 1/2 year]
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The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.
[Time Frame: A duration of the whole research stage, an expected average of 1/2 year]
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Number increase of Renal nerves in patients with sympathetic over-activity diseases
[Time Frame: A duration of the whole research stage, an expected average of 1/2 year]
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Secondary Outcome(s)
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Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure
[Time Frame: Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours]
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Secondary ID(s)
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US-RNRE
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NSFC81370440
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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