Intravascular Ultrasound Evaluation of Renal Nerves in Different Diseases

NCT02243514 | Unknown DMC

• 2 other identifiers: US-RNRENSFC81370440
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an important part in the autonomic nervous system regulation, especially in cardiovascular system, the modulation of the renal nerves used as a therapeutic strategy has been researched across the world. The purpose of this study is to evaluate and quantify the morphology changes in different diseases, make the modulation therapy more selective and effective.

Conditions

Hypertension; Heart Failure

Keywords

Hypertension; Heart failure; Sympathetic hyperactivity; Renal nerve; Remodeling; Nerve remodeling

Outcome Measures

Primary Outcomes (3)

• Number increase of Renal nerves in patients with sympathetic over-activity diseases

  Total number of the renal nerve of each patient(automatic identification by the embedded software in the ultrasound imaging host/counting manually): Number of Nerve Bundles;

  A duration of the whole research stage, an expected average of 1/2 year

• Area increase of Renal nerves in patients with sympathetic over-activity diseases

  Total area of the renal nerve (measured by ultrasound imaging host) of each patient: square millimeter (mm²)=∑= Nerve 1(length\*width)+ Nerve 2(length\*width)+ ......+ Nerve n(length\*width);

  A duration of the whole research stage, an expected average of 1/2 year

• The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.

  1. Renal artery area of each patient (measured by ultrasound imaging host): Square millimeter (mm²); 2. Renal arterial wall area (measured by ultrasound imaging host) of each patient: Square millimeter (mm²); 3. Total area of the renal nerve/Total renal artery area: percentage (%); 4. Total area of the renal nerve/Total renal arterial wall area: percentage (%);

  A duration of the whole research stage, an expected average of 1/2 year

Secondary Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure

  Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours

Study Arms (4)

Resistant hypertension

Essential hypertension

Chronic heart failure

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients who are going to take a vascular interventional examination.

You may qualify if:

• 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
• 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
• 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
• Control group
• no history of arterial hypertension, heart failure and diabetes
• going to take a vascular interventional examination during hospitalization

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The 2nd Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related Publications (2)

• Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.

  PMID: 24678939 BACKGROUND

• D'Elia E, Pascale A, Marchesi N, Ferrero P, Senni M, Govoni S, Gronda E, Vanoli E. Novel approaches to the post-myocardial infarction/heart failure neural remodeling. Heart Fail Rev. 2014 Sep;19(5):611-9. doi: 10.1007/s10741-013-9415-6.

  PMID: 24292688 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, urine, stool

MeSH Terms

Conditions

Hypertension; Heart Failure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Jing Huang, MD

  Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Huang, MD

CONTACT

0086-13508312022; huangjing@cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Director, Department of Cardiology

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 18, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

CN (1)