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

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ClinicalTrials.gov Identifier: NCT00491907
Recruitment Status : Terminated (recruitment is finished)
First Posted : June 26, 2007
Last Update Posted : October 2, 2007
Information provided by:
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: folic acid 5mg/day Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure
Study Start Date : October 2004
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. change in endothelial function [ Time Frame: 1 month ]
  2. change in baroreceptor function [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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): NCT00491907

Sponsors and Collaborators
University of Zurich
Principal Investigator: Georg Noll, MD Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland

ClinicalTrials.gov Identifier: NCT00491907     History of Changes
Other Study ID Numbers: FolicAcid881
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: October 2007

Keywords provided by University of Zurich:
folic acid
endothelial function
baroreceptor function
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs