Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction (DIASTOLE)
Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in the clinical phenomena of heart failure with normal left ventricular ejection fraction and hypertension. The current study aims to evaluate efficacy and safety of renal sympathetic denervation for the modulation of the SNS in patients with heart failure with normal LV ejection fraction.
Diastolic Heart Failure
Procedure: renal denervation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sympathetic Renal Denervation in Heart Failure With Normal LV Ejection Fraction: Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction|
- Change from baseline E/E' at 12 months [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]Echocardiography will be used to measure the E/E'
- Number of participants with adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Renal denervation
Procedure: renal denervation
No Intervention: control
Rationale: Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in the clinical phenomena of heart failure with normal left ventricular ejection fraction and hypertension. Moreover, sympathetic activation of the kidneys is directly proportional related to the severity of the heart failure state. Therapeutic renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity. The current study aims to evaluate efficacy and safety of renal sympathetic denervation for the modulation of the SNS in patients with heart failure with normal LV ejection fraction.
Objective: Primary objectives: To investigate the efficacy of PRDN by means of pulsed wave Doppler echocardiographic parameters in patients diagnosed with HFNEF and hypertension. Secondary objectives: to investigate the safety of PRDN in patients with heart failure with normal LV ejection fraction and hypertension and to compare changes in the following parameters in patients with HFNEF and hypertension after PRDN: LV mass, LV volume, LA volume, LVEF, MIBG-uptake and -washout, BNP levels, blood pressure, heart rate variability, exercise capacity and quality of life.
Study design: Multicentre, prospective, randomised controlled trial. 60 patients will be randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment (n=30) or to maintain previous treatment alone (n=30) at 2 participating centres. Randomisation will be done with sealed envelopes.
Study population: Patients diagnosed with heart failure with normal LV ejection fraction and treated for hypertension. Patients should have a stable drug regimen, with at least 2 antihypertensive agents. This drug regimen should be expected to be maintained for at least 6 months.
￼￼￼￼￼￼￼￼￼Endpoints: The efficacy of PRDN will be evaluated primarily using echocardiographic parameters. Also, safety of PRDN on major and minor adverse events, LV mass, LV and LA dimensions, MIBG uptake and clinical endpoints will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583881
|Contact: Willemien Verloop, MDfirstname.lastname@example.org|
|Contact: Michiel Voskuil, MD, PhD|
|Contact: Cor Allaart, MD, PhD email@example.com|
|Contact: Willemien Verloop, MD firstname.lastname@example.org|
|Contact: Voskuil, MD, PhD email@example.com|
|Principal Investigator:||Michiel Voskuil, MD, PhD||UMC Utrecht|