Clinical trial NCT02243514: Intravascular Ultrasound Evaluation of Renal Nerves in Different Diseases
Official title: Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Heart Failure
Keywords: Hypertension
Heart failure
Sympathetic hyperactivity
Renal nerve
Remodeling
Nerve remodeling
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients who are going to take a vascular interventional examination.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number increase of Renal nerves in patients with sympathetic over-activity diseases
timeFrame: A duration of the whole research stage, an expected average of 1/2 year
measure: Area increase of Renal nerves in patients with sympathetic over-activity diseases
timeFrame: A duration of the whole research stage, an expected average of 1/2 year
measure: The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.
timeFrame: A duration of the whole research stage, an expected average of 1/2 year
Secondary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure
timeFrame: Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The 2nd Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University
name: Jing Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.