Clinical trial NCT01733901: Renal Sympathetic Denervation as Secondary Prevention for Patients After Percutaneous Coronary Intervention.
Official title: Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation as a Method of Secondary Prevention for Patients After Percutaneous Coronary Intervention.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease
PCI
Renal sympathetic denervation
Hypertension
Diabetes
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study whether renal sympathetic denervation(RSD) will reduce the all-cause mortality and the recurrence rate of a composite of cardiovascular event(including angina, myocardial infarction, repeat percutaneous coronary intervention and coronary artery bypass grafting) in patients after percutaneous coronary intervention(PCI). Besides whether RSD can reduce the risk factors for coronary heart disease.

Detailed description: Coronary heart disease is the leading cause of death worldwide, contributing to over 7.2 million deaths annually. The main measures of secondary prevention of coronary heart disease are optimizing drug therapy and changing lifestyle. optimizing drug therapy, including aspirin, beta receptor blockers, lipid regulating drugs (mostly statins, a small part fibrates) and vascular angiotensin-converting enzyme inhibitors. However, the situation for secondary prevention of coronary heart disease is not satisfying. EuroASPIRE III survey found that despite effective drug used in the primary or secondary prevention of coronary heart disease, coronary heart disease risk factors, such as high blood glucose,hypertension, high cholesterol and obesity, are still poorly controlled. At the same time sympathetic activation plays an extremely important role in the development of coronary heart disease, and high sympathetic activity after acute myocardial infarction is closely related to malignant arrhythmia and heart failure. Recently, many clinical researches have verified that catheter-based renal sympathetic denervation(RSD) can safely be used to substantially reduce blood pressure, reduce left ventricular hypertrophy, improve glucose tolerance and sleep apnea severity. Simultaneously, a marked reduction in muscle and whole-body sympathetic-nerve activity(MSNA) is apparent, with a decrease in renal and whole-body norepinephrine spillover. Hypertension, diabetes, high norepinephrine level and obstructive sleep apnea are all recognized as risk factors for the development and recurrence of coronary heart disease. So, we design this randomized parallel control clinical study to demonstrate whether RSD can reduce the mortality and the recurrence rate of a composite of cardiovascular event in patients after PCI, besides whether RSD can reduce the risk factors for coronary heart disease.

Eligibility criteria: Inclusion Criteria:

1. Individual is ≥ 18 and ≤75 years of age.
2. Individual has a clear history of coronary heart disease,and need underwent percutaneous coronary intervention .
3. Blood pressure \>115/75mmHg.
4. Individual's cardiac function is between Ⅰ\~Ⅲ level(NYHA)
5. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

1. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
2. Individual has experienced renal artery stenosis,or A history of prior renal artery intervention including balloon angioplasty or stenting. or ineligible conditions through renal artery Computed Tomography Angiogram(CTA) inspection, such as double renal artery on one side,renal artery length≤2cm, diameter≤4mm, and distortion at incept sect.
3. Individual has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD calculation.
4. Individual has Acute heart failure.
5. Individual has experienced a cerebrovascular accident within 3 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
6. Individual has experienced sick sinus syndrome.
7. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
8. Individual is pregnant, nursing or planning to be pregnant. \[Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.\]
9. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
10. Individual is currently enrolled in another investigational drug or device trial.

Primary outcomes:
measure: All-cause mortality
timeFrame: 24 months
Secondary outcomes:
measure: Recurrent angina pectoris
timeFrame: 24 months
measure: Myocardial infarction
timeFrame: 24 months
measure: Vascular recanalization again
timeFrame: 24 months
measure: Chronic heart failure
timeFrame: 24 months
measure: Arrhythmia
timeFrame: 24 months
measure: Stroke
timeFrame: 24 months
measure: Blood pressure
timeFrame: 24 months
measure: Blood sugar
timeFrame: 24 months
measure: Renal function
timeFrame: 24 months
measure: Pulse wave velocity
timeFrame: 24 months
measure: Life quality
timeFrame: 24 months
measure: Medication adherence
timeFrame: 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Qijun Shan, professor
role: STUDY_CHAIR
References: