Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction (DIASTOLE)
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|ClinicalTrials.gov Identifier: NCT01583881|
Recruitment Status : Unknown
Verified October 2015 by Michiel Voskuil, MD, PhD, UMC Utrecht.
Recruitment status was: Active, not recruiting
First Posted : April 24, 2012
Last Update Posted : November 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diastolic Heart Failure Hypertension||Procedure: renal denervation||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||July 2016|
Experimental: Renal denervation
Procedure: renal denervation
No Intervention: control
- Change from baseline E/E' at 12 months [ Time Frame: 12 months after treatment ]Echocardiography will be used to measure the E/E'
- Number of participants with adverse events [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583881
|Principal Investigator:||Michiel Voskuil, MD, PhD||UMC Utrecht|