Renal Denervation in Patients With Heart Failure and Severe Left Ventricular Dysfunction.

NCT01870310 | Unknown

• 1 other identifier: OLOMOUC 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized prospective controlled study evaluating the effect of transcatheter renal denervation on the clinical status of patients with chronic heart failure and its safety procedures. The working hypothesis of the study is that by performing transcatheter renal denervation in patients with chronic heart failure and severe left ventricular systolic dysfunction there will a resultant reduction in the renal sympathetic activation which in turn will reduce the number of hospitalizations and deaths from heart failure.

Conditions

Heart Failure

Keywords

Heart failure; Renal denervation

Outcome Measures

Primary Outcomes (1)

• Change in serum NT-proBNP at 6 months and 1 year from baseline in both groups.

  The level of NT-proBNP (N-terminal prohormone of Brain Natriuretic Peptide) is a reliable indicator of the severity of heart failure. Lowering levels will indicate improvement in the heart function.

  6 months and 1 year

Secondary Outcomes (1)

• Reduction in the number of hospitalizations and/or deaths due to cardiovascular causes.

  1 year to 4 years

Other Outcomes (1)

• Significant Renal impairment and symptomatic hypotension.

  6 months to 1 year

Study Arms (2)

Standard medical therapy

NO INTERVENTION

Renal denervation + standard medical therapy

EXPERIMENTAL

Patients in this arm will undergo catheterised renal denervation in addition to having optimization of medical therapy for heart failure.

Procedure: Catheterised renal denervation

Interventions

Catheterised renal denervation PROCEDURE

Also known as: Symplicity, Ardian / Medtronic, USA

Renal denervation + standard medical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age with chronic heart failure, ischemic and non-ischemic etiology.
• NYHA (New York Heart Association) class II-IV.
• LVEF (Left Ventricular Ejection Fraction) ≤ 35%.
• Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure, who were stable for at least four weeks without acute decompensated heart failure.
• Prior to enrollment, patients must give informed consent.

You may not qualify if:

• Patients with history of acute coronary syndrome or stroke within the last 6 months.
• Significant valvular defects and/or planned cardiac surgery.
• Systolic blood pressure \<110 mmHg.
• Advanced renal insufficiency (estimated GFR (Glomerular Filtration Rate) according to MDRD \<30 ml/min/1.73 square meters).
• Unsuitable anatomy of renal arteries (presence of significant renal stenosis, renal artery narrower than 4 mm).
• Patients who underwent renal angioplasty or stent placement into the renal artery in the past.
• Severe coagulation disorders.
• Pregnancy or lactation.
• Refusal of the patient.
• Other diseases limiting prognosis of the patient to less than 2 years.
• Other reasons which in the opinion of the attending physician would preclude the individual from participating in the study.

Sponsors & Collaborators

• University Hospital Olomouc: lead

Study Sites (1)

University Hospital, Olomouc

Olomouc, Olomouc, 775 20, Czechia

RECRUITING

Related Publications (11)

• Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. No abstract available.

  PMID: 18799522 BACKGROUND

• Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55. doi: 10.1056/NEJM199605233342101.

  PMID: 8614419 BACKGROUND

• Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999 Jun 12;353(9169):2001-7.

  PMID: 10376614 BACKGROUND

• The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999 Jan 2;353(9146):9-13.

  PMID: 10023943 BACKGROUND

• van Veldhuisen DJ, Cohen-Solal A, Bohm M, Anker SD, Babalis D, Roughton M, Coats AJ, Poole-Wilson PA, Flather MD; SENIORS Investigators. Beta-blockade with nebivolol in elderly heart failure patients with impaired and preserved left ventricular ejection fraction: Data From SENIORS (Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalization in Seniors With Heart Failure). J Am Coll Cardiol. 2009 Jun 9;53(23):2150-8. doi: 10.1016/j.jacc.2009.02.046.

  PMID: 19497441 BACKGROUND

• Petersson M, Friberg P, Eisenhofer G, Lambert G, Rundqvist B. Long-term outcome in relation to renal sympathetic activity in patients with chronic heart failure. Eur Heart J. 2005 May;26(9):906-13. doi: 10.1093/eurheartj/ehi184. Epub 2005 Mar 10.

  PMID: 15764611 BACKGROUND

• DiBona GF, Kopp UC. Neural control of renal function. Physiol Rev. 1997 Jan;77(1):75-197. doi: 10.1152/physrev.1997.77.1.75.

  PMID: 9016301 BACKGROUND

• Clayton SC, Haack KK, Zucker IH. Renal denervation modulates angiotensin receptor expression in the renal cortex of rabbits with chronic heart failure. Am J Physiol Renal Physiol. 2011 Jan;300(1):F31-9. doi: 10.1152/ajprenal.00088.2010. Epub 2010 Oct 20.

  PMID: 20962112 BACKGROUND

• SMITHWICK RH. Hypertensive vascular disease; results of and indications for splanchnicectomy. J Chronic Dis. 1955 May;1(5):477-96. doi: 10.1016/0021-9681(55)90061-8. No abstract available.

  PMID: 14367447 BACKGROUND

• Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.

  PMID: 19332353 BACKGROUND

• Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.

  PMID: 21093036 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Miloš Táborský, doc., MUDr., CSc., FESC, MBA

  Head of Department of First Clinic of Internal Medicine - Cardiology, University Hospital, Olomouc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dagmar Strnkova, Mgr.

CONTACT

+420 588 443 716; dagmarstrnkova@seznam.cz

Albert Louis, MUDr.

CONTACT

+420 588 443 238; albertlouis3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of First Clinic of Internal Medicine - Cardiology

Study Record Dates

• First Submitted: May 25, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2016
• Last Updated: June 6, 2013

Record last verified: 2013-06

Locations

CZ (1)