Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Jagiellonian University

Status and phase: Unknown; Phase 2

Conditions: Heart Failure

Treatments: Procedure: renal denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT02329145

204069

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Active treatment

Experimental group

Description:

Renal denervation

Treatment:

Procedure: renal denervation

Observational

No Intervention group