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Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

NCT ID: NCT02329145

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Keywords

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renal denervation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active treatment

Renal denervation

Group Type EXPERIMENTAL

renal denervation

Intervention Type PROCEDURE

Observational

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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renal denervation

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Aleksander Kusiak

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ist Department of Cardiology, Interventional Electrocardiology and Hypertension

Krakow, Malopolska, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Aleksander Kusiak, PhD,MD

Role: CONTACT

Phone: +48124247300

Email: [email protected]

Facility Contacts

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Aleksander Kusiak, MD, PHD

Role: primary

Other Identifiers

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204069

Identifier Type: -

Identifier Source: org_study_id