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Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

renal denervation

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring renal denervation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age ≥ 18 year
heart failure patients NYHA Class II - IV
implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier
symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)
left ventricular ejection function ≤ 35%
glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2)
patient informed consent for participation in the study

Exclusion Criteria:

renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)
history of prior renal artery intervention
single functioning kidney
clinic systolic BP < 110mmHg
pregnancy
acute coronary syndrome or cerebrovascular event within last 3 months
serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)

Sites / Locations

Ist Department of Cardiology, Interventional Electrocardiology and HypertensionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active treatment

Observational

Arm Description

Renal denervation

Outcomes

Primary Outcome Measures

Number of hospitalizations due to heart failure worsening.

Change in NYHA class.

Change in 6 minute walk test distance.

Secondary Outcome Measures

Full Information

NCT ID

NCT02329145

First Posted

December 23, 2014

Last Updated

December 29, 2014

Sponsor

Jagiellonian University

1. Study Identification

Unique Protocol Identification Number

NCT02329145

Brief Title

Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Official Title

Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jagiellonian University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

renal denervation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active treatment

Arm Type

Experimental

Arm Description

Renal denervation

Arm Title

Observational

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

renal denervation

Primary Outcome Measure Information:

Title

Number of hospitalizations due to heart failure worsening.

Time Frame

one year

Title

Change in NYHA class.

Time Frame

one year

Title

Change in 6 minute walk test distance.

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age ≥ 18 year heart failure patients NYHA Class II - IV implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure) left ventricular ejection function ≤ 35% glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2) patient informed consent for participation in the study Exclusion Criteria: renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length) history of prior renal artery intervention single functioning kidney clinic systolic BP < 110mmHg pregnancy acute coronary syndrome or cerebrovascular event within last 3 months serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aleksander Kusiak, PhD,MD

Phone

+48124247300

alek.kusiak@gmail.com

Facility Information:

Facility Name

Ist Department of Cardiology, Interventional Electrocardiology and Hypertension

City

Krakow

State/Province

Malopolska

ZIP/Postal Code

31-501

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aleksander Kusiak, MD, PHD

Phone

+48124247300

alek.kusiak@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

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