Heart Failure Clinical Trial
Official title:
Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure
The randomized, double-blind, placebo-controlled study aim to evaluate the effect of 1-month
therapy with folic acid (5 mg/day) on endothelial function and baroreceptor function in
patients with heart failure.
Endothelial function will be studied non-invasively with flow-mediated dilation while for
eveluating baroreceptor function sympathetic nervous system activity will be measured
directly with microneurography in baseline condition and during infusion of
sodium-nitroprusside.
Endothelial and baroreceptor function are impaired in patients with heart failure.
Impaired baroreflex control of the heart and peripheral circulation and endothelial
dysfunction are thought to play an important pathophysiological role in chronic heart
failure and confers a poor prognosis.
In patients with essential hypertension we demonstrated an improvement in baroreceptor
function after treatment with folic acid.
Therefore, the aim of the present randomized, double-blind, placebo-controlled study was to
evaluate endothelial function and baroreceptor function in patients with heart failure
before and after 1-month therapy with folic acid (5 mg) or placebo.
Endothelial function will be assessed with novel high-resolution ultrasound devices, which
allows to investigate endothelial function in vivo. This method makes use of the property of
the endothelium to release nitric oxide in response to shear stress and increased flow as
previously described. Endothelium-dependent flow-mediated dilation (FMD) and
endothelium-independent glycerol trinitrate (GTN) (0.4 mg sublingual, Nitrolingual Spray,
Pohl-Boskamp, Germany)-induced vasodilation of the brachial artery will be assessed by a
high-resolution ultrasound vessel wall tracking device with a 10 MHz linear array transducer
. FMD of the brachial artery is induced by release of a wrist cuff inflated 50 mmHg above
systolic pressure for 5 minutes. After sublingual GTN application, used as
endothelium-independent stimulus, the diameter will be recorded every 30 seconds for 6
minutes.
Multifiber recordings of muscle sympathetic nerve activity will be obtained from the
peroneal nerve posterior to the fibular head with tungsten microelectrodes. The sympathetic
nervous activity will be measured continuously together with ECG, respiration rate and blood
pressure. Baroreceptor modulation of muscle sympathetic nerve activity and heart rate would
be assessed by intravenous infusion of sodium nitroprusside.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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