Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Heart Failure Clinical Trial

Official title:

Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02329145
• Other study ID #: 204069
• Status: Recruiting
• Phase: Phase 2
• First received: December 23, 2014
• Last updated: December 29, 2014
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: Jagiellonian University
• Contact: Aleksander Kusiak, PhD,MD
• Phone: +48124247300
• Email: alek.kusiak[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

Chronic heart failure is becoming more and more common disease and activation of sympathetic nervous system plays a crucial role in its development. There is some data allowing to suspect that one of the new treatment methods- renal denervation, also in patients with chronic heart failure may lead to decrease of systemic activity sympathetic nervous system and, as a consequence, to decrease of disease progression. The research hypothesis is whether renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is used (including resynchronization therapy), is contributing to the improvement in parameters of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far only very limited data- mostly case reports- are available in this study area.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age = 18 year

2. heart failure patients NYHA Class II - IV

3. implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier

4. symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)

5. left ventricular ejection function = 35%

6. glomerular filtration rate (eGFR according to MDRD formula = 30 mL/min/1.73m2)

7. patient informed consent for participation in the study

Exclusion Criteria:

1. renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)

2. history of prior renal artery intervention

3. single functioning kidney

4. clinic systolic BP < 110mmHg

5. pregnancy

6. acute coronary syndrome or cerebrovascular event within last 3 months

7. serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• renal denervation

Locations

Country	Name	City	State
Poland	Ist Department of Cardiology, Interventional Electrocardiology and Hypertension	Krakow	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospitalizations due to heart failure worsening.		one year	Yes
Primary	Change in NYHA class.		one year	Yes
Primary	Change in 6 minute walk test distance.		one year	Yes