Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

NCT02329145 | Unknown Phase 2

• 1 other identifier: 204069
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

renal denervation

Outcome Measures

Primary Outcomes (3)

• Number of hospitalizations due to heart failure worsening.

  one year

• Change in NYHA class.

  one year

• Change in 6 minute walk test distance.

  one year

Study Arms (2)

Active treatment

EXPERIMENTAL

Renal denervation

Procedure: renal denervation

Observational

NO INTERVENTION

Interventions

renal denervation PROCEDURE

Active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Ist Department of Cardiology, Interventional Electrocardiology and Hypertension

Krakow, Malopolska, 31-501, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Aleksander Kusiak, PhD,MD

CONTACT

+48124247300; alek.kusiak@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 31, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

PL (1)