Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT01583881 |
Other study ID # |
12-046 |
Secondary ID |
|
Status |
Terminated |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
April 1, 2012 |
Est. completion date |
July 1, 2016 |
Study information
Verified date |
April 2021 |
Source |
UMC Utrecht |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.