Does Ascorbic Acid Reduce Sympathoexcitation in CHF? | NCT00550121

Studies
Does Ascorbic Acid Reduce Sympathoexcitation in CHF?

NCT00550121

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Oct 15, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Heart Failure

Interventions

vitamin C
placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Apr 2008Actual

First Submitted Date

Oct 25, 2007

First Submission Date that Met QC Criteria

Oct 25, 2007

First Posted Date

Oct 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2008

Last Update Posted Date

Oct 15, 2008Estimated

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER

Description Module

Brief Summary

In CHF central sympathetic activity is increased. ROS formation seems to play a role in this process. This study analyzes the effect of vitamin C as an antioxidant on central sympathetic activity in CHF

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
1	Experimental		Drug: vitamin C
2	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
vitamin C	Drug		1
placebo

Measure	Description	Time Frame
change in central sympathetic output after vitamin C vs. placebo

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart failure of at least New York Heart Association (NYHA) class II
Left ventricular ejection fraction (LVEF) <= 40%
Age 20-80 years

Exclusion Criteria:

Necessity of short-term PCI, CABG or heart transplantation,
Chronic disease of the autonomic nervous system,
diabetes mellitus,
use of tricyclic antidepressant drugs and/or a-adrenergic receptor antagonists.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cees J Tack, MD, PhD	Radboud University Medical Centre Nijmegen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Centre		Nijmegen		6500 HB	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided