NCT00491907

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2004

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

October 2, 2007

Status Verified

October 1, 2007

First QC Date

June 25, 2007

Last Update Submit

October 1, 2007

Conditions

Heart Failure

Keywords

folic acidendothelial functionbaroreceptor functionheart failure

Outcome Measures

Primary Outcomes (2)

  • change in endothelial function

    1 month

  • change in baroreceptor function

    1 month

Interventions

folic acid 5mg/dayDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Georg Noll, MD

    Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 26, 2007

Study Start

October 1, 2004

Study Completion

May 1, 2007

Last Updated

October 2, 2007

Record last verified: 2007-10