Heart FailureNCT00550121
Does Ascorbic Acid Reduce Sympathoexcitation in CHF?
A study testing vitamin C in people with Heart Failure, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Aug 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Heart failure of at least New York Heart Association (NYHA) class II
- Left ventricular ejection fraction (LVEF) <= 40%
- Age 20-80 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
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
- Conditions
- Heart Failure
- Being tested
- vitamin C, placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin CDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: vitamin C |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in central sympathetic output after vitamin C vs. placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startAug 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Cees J Tack, MD, PhD, Principal investigator, Radboud University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550121
- Sponsor's protocol ID
- CHFVIT
- Status last verified
- Oct 2008
- First submitted
- 25 Oct 2007
- Last updated
- 15 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ascorbic Acid Reduce Sympathoexcitation in CHF?
- ClinicalTrials.gov ID
- NCT00550121
- Acronym / sponsor ID
- CHFVIT
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Aug 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 26 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vitamin C |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heart failure of at least New York Heart Association (NYHA) class II
- Left ventricular ejection fraction (LVEF) <= 40%
- Age 20-80 years
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin C | Drug | 1 |
| placebo | Drug | 2 |
Primary outcome
change in central sympathetic output after vitamin C vs. placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cees J Tack, MD, PhD principal investigator
Radboud University Medical Centre Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin C in people with Heart Failure, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in central sympathetic output after vitamin C vs. placebo. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.