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Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure

Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00491907
Enrollment
Unknown
Registered
2007-06-26
Start date
2004-10-31
Completion date
2007-05-31
Last updated
2007-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

folic acid, endothelial function, baroreceptor function, heart failure

Brief summary

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.

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) (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.

Interventions

DRUGfolic acid 5mg/day

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Heart failure (min. NYHA ll, LVEF \<50%) * Not smokers * Written informed consent

Exclusion criteria

* Unstable heart failure * Smoking * Unstabile Angina Pectoris * Endocrinologic disease such as Diabetes mellitus, Hypo- und Hyperthyroidism * Alcohol abuse * Epilepsia * Treatment with folic acid antaponists Trimethoprim, Pyrimethamin, Methotrexat.. * Participation to one other clinical Study within 1 Month

Design outcomes

Primary

MeasureTime frame
change in endothelial function1 month
change in baroreceptor function1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026