Renal Sympathetic Modification in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

Renal Sympathetic Modification in Patients With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01402726
• Other study ID #: SWAN-HF
• Status: Recruiting
• Phase: N/A
• Start date: July 2011
• Est. completion date: June 2020

Study information

• Verified date: March 2019
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Yuehui Yin, MD
• Phone: 0086-13508335502
• Email: yinyh63[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.

Description:

Heart failure is a clinical syndrome of chronic cardiac dysfunction, with high morbidity and mortality. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that partly blocking sympathetic nerves activity contributed to improve cardiac function in patients with heart failure. Renal ablation with sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. The investigators hypothesis that renal sympathetic nerves modification is effective and safe in improving cardiac function. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary anti-heart failure drugs besides expectant intervention, and patients in control group will receive appropriate anti-heart failure drugs only. The investigators aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• = 18 years old, and = 75 years old of age

• more than half a year history of heart failure, except for valvular heart disease

• heart failure patients NYHA Class II III IV

• left ventricular ejection function = 40% or = 45% (that is heart failure with preserved ejection fraction) with Simpson's method

• estimated glomerular filtration rate (eGFR) of = 45mL/min

• is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

• patients with acute heart failure

• patients with acute coronary syndrome

• estimated glomerular filtration rate (eGFR) of < 45mL/min

• has the history of renal restenosis or renal stents implantation

• has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months

• patients with sick sinus syndrome

• pregnant women

• mental disorders

• patients that have allergy to contrast agent

• patients that do not go with follow-up

• others such as researcher considers it is not appropriate to be included into the study

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure

Locations

Country	Name	City	State
China	2ndChongqingMU	Chongqing	Chongqing

Sponsors (3)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University	Chongqing Medical University, Jiangsu Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite cardiovascular events	Comprising myocardial infarction, heart failure, sudden death, cardiogenic death	three years