Renal Sympathetic Denervation for Patients With Chronic Heart Failure (RSD4CHF)
Chronic Heart Failure
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Renal Sympathetic Denervation
Eligibility Criteria
Inclusion Criteria:
- Individual is ≥18 and ≤ 75 years of age
- Individual has a history of heart failure more than half a year
- Individual's Cardiac function is betweenⅡ-Ⅳlevel(NYHA)
- Ejection fraction ≦ 35%
- Renal artery CTA (computed tomographic arteriography)inspection renal artery length ≧ 2 cm, diameter ≧ 4 mm, no single double renal artery, renal artery start without distortion/tumor sample expansion,ect
- 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:
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Individual has experienced renal artery stenosis,or A history of prior renal artery intervention including balloon angioplasty or stenting.
- Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD(Modification of Diet in Renal Disease) calculation.
- Individual has Acute heart failure.
- Individual has experienced a cerebrovascular accident within 3 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has experienced sick sinus syndrome.
- 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).
- 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.]
- 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.
- Individual is currently enrolled in another investigational drug or device trial.
Sites / Locations
- First Affiliated Hospital of Nanjing Meddical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
RSD+Conventional therapy
Conventional therapy
We will recruit 100 randomised CHF patients who meet the inclusion criteria.First undergo renal artery angiography procedure to confirm anatomy.If renal artery meet the inclusion criteria,give the renal sympathetic denervation.At the same time, we will use conventional therapy to protect cardiac function.then we will conduct a clinic follow-up and a telephone follow-up.
We also will recruit 100 randomised CHF patients who meet the inclusion criteria.there are no significant differences in age,gender,race,past medical history,personal history and so on between the two groups.In this group we will use therapy just like the RSD+Conventional therapy group.we will conduct a clinic and a telephone follow-up.