Intravascular Ultrasound Evaluation of Renal Nerves in Different Diseases

Hypertension Clinical Trial

Official title:

Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243514
• Other study ID #: US-RNRE
• Secondary ID: NSFC81370440
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2014
• Last updated: October 22, 2014
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2014
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Jing Huang, MD
• Phone: 0086-13508312022
• Email: huangjing[@]cqmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

People eligible for this study will be divided into 4 groups according to the eligibility criteria(Resistant Hypertension Group,Essential Hypertension Group, Chronic Heart Failure Group and Control Group), about 15 objects for each, totally 60 objects are going to be recruited.

Before the intravascular ultrasound examination, ambulatory blood pressure, ECG, plasma catecholamine hormones, renin-angiotension-aldosterone, ect. will be measured. An intravascular ultrasound examination will be taken after all of these have been done.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Failure
• Hypertension

Locations

Country	Name	City	State
China	The 2nd Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.	Renal artery area of each patient (measured by ultrasound imaging host): Square millimeter (mm²); Renal arterial wall area (measured by ultrasound imaging host) of each patient: Square millimeter (mm²); Total area of the renal nerve/Total renal artery area: percentage (%); 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	No
Secondary	Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure	Renal arteriography will be carried out post operation to evaluate the possibility of renal artery injuries caused by this procedure, which including: Emerging renal artery dissection; Emerging renal artery stenosis, which will not improve by the intravascular injection of nitroglycerin; Emerging renal artery rupture or perforate; Contrast-induced nephropathy; Any other complications related to this intervention procedure, such as catheter breakage, infection, hematoma ect.	Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours	Yes