Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00491907
Status:
TERMINATED
Last Update Posted:
2007-10-02
First Post:
2007-06-25
Brief Title:
Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment is finished
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The randomized double-blind placebo-controlled study aim to evaluate the effect of 1-month therapy with folic acid 5 mgday 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 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
Detailed Description:
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 04 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
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 04 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None