Fontan ProcedureNCT00974025
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
A study testing Vitamin C in people with Fontan Procedure and Hypoplastic Left Heart Syndrome, run by University of Michigan at 1 site in United States.
Trial summary
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology. Read more about this study
- Who is it for?
- Ages 8 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
- What is being tested?
- Vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Mar 2010
- 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 8 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 8-25 years of age
- Fontan-palliated patient
Who cannot join
- New York Heart Association (NYHA) classes III or IV
- Diabetes mellitus
- Family history of premature coronary artery disease
- Use of Sildenafil or other pulmonary artery vasodilators
- Prior cardiac arrest (outside the first 24-hours postoperatively)
- Life-threatening dysrhythmias
Show all 10Show fewer
- Severe ventricular dysfunction
- Severe AV valve regurgitation
- Pregnancy
- Severe renal or hepatic impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin C May Improve Endothelial Function and Exercise Capacity in Functional Single Ventricle Patients After Fontan Palliation
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved exercise tolerance and endothelial function in patients who have undergone the Fontan operation, compared to placebo.
Read the detailed description
Recent evidence suggests that after Fontan operation, single ventricle patients have impaired function of the vascular endothelium due in part to abnormalities in nitric oxide signaling. Endothelial dysfunction may contribute to the development of congestive heart failure and exercise intolerance that have been well-documented in Fontan patients. Therapeutic interventions to improve endothelial function in adults with heart failure have mainly focused on increasing the synthesis or decreasing the degradation of nitric oxide. We propose a randomized, prospective, placebo-controlled trial of vitamin C, an antioxidant that protects NO deactivation, in subjects with single ventricular anatomy after Fontan palliation. The specific aims of this study are to compare NO signaling, endothelial function and exercise capacity in Fontan subjects to that of a control group that is frequency-matched to case subjects by age and sex, and to assess NO signaling, endothelial function and exercise capacity in Fontan subjects after 4 weeks of oral vitamin C (or placebo) therapy. These results have particular importance because improving the endothelial response in Fontan patients has the potential to reduce the risk of developing congestive heart failure and improve exercise capacity. Furthermore, assessing endothelial function and the effects of therapies aimed at improving vascular health may be generalizable to many other chronic pediatric conditions associated with increased cardiovascular risk such as obesity, diabetes mellitus, and hypertension.
- Being tested
- Vitamin C, Placebo
- Medical subject headings
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
High-dose Vitamin C will be administered in 4 age-based dosing groups
PlaceboDietary supplement
Placebo will be administered twice daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | High-dose Vitamin C in 4 age-based doses will be given in two-daily doses for four weeks Receives: Dietary Supplement: Vitamin C |
| Placebo | Placebo comparator | Placebo will be given in two-daily doses for four weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen consumption (from baseline to post-study drug testing)
Measured: 4 weeks
Secondary outcomes (6)
Oxygen Pulse
Measured: 4 weeks
Peak Work
Measured: 4 weeks
Endo-PAT score
Measured: 4 weeks
Framingham Modified Endothelial Function Score
Measured: 4 weeks
PedsQL 4.0 - quality of life assessment
Measured: 4 weeks
BNP
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fontan ProcedureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Griese-Hutchinson Champions for Children's Hearts Investigator Award
- Responsible party
- Principal investigator, John R. Charpie, University of Michigan
- Investigators
- John R Charpie, MD, Study director, University of MichiganBryan H Goldstein, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974025
- Sponsor's protocol ID
- HUM00029464
- Status last verified
- May 2017
- First submitted
- 9 Sep 2009
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldstein BH, Golbus JR, Sandelin AM, Warnke N, Gooding L, King KK, Donohue JE, Gurney JG, Goldberg CS, Rocchini AP, Charpie JR. Usefulness of peripheral vascular function to predict functional health status in patients with Fontan circulation. Am J Cardiol. 2011 Aug 1;108(3):428-34. doi: 10.1016/j.amjcard.2011.03.064. Epub 2011 May 19.
PubMed 21600541Goldstein BH, Sandelin AM, Golbus JR, Warnke N, Gooding L, King KK, Donohue JE, Yu S, Gurney JG, Goldberg CS, Rocchini AP, Charpie JR. Impact of vitamin C on endothelial function and exercise capacity in patients with a Fontan circulation. Congenit Heart Dis. 2012 May-Jun;7(3):226-34. doi: 10.1111/j.1747-0803.2011.00605.x. Epub 2011 Dec 18.
PubMed 22176653
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C May Improve Endothelial Function and Exercise Capacity in Functional Single Ventricle Patients After Fontan Palliation
- ClinicalTrials.gov ID
- NCT00974025
- Acronym / sponsor ID
- HUM00029464
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Griese-Hutchinson Champions for Children's Hearts Investigator Award
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Sep 2009 (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 this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved exercise tolerance and endothelial function in patients who have undergone the Fontan operation, compared to placebo.
Detailed description
Recent evidence suggests that after Fontan operation, single ventricle patients have impaired function of the vascular endothelium due in part to abnormalities in nitric oxide signaling. Endothelial dysfunction may contribute to the development of congestive heart failure and exercise intolerance that have been well-documented in Fontan patients. Therapeutic interventions to improve endothelial function in adults with heart failure have mainly focused on increasing the synthesis or decreasing the degradation of nitric oxide. We propose a randomized, prospective, placebo-controlled trial of vitamin C, an antioxidant that protects NO deactivation, in subjects with single ventricular anatomy after Fontan palliation. The specific aims of this study are to compare NO signaling, endothelial function and exercise capacity in Fontan subjects to that of a control group that is frequency-matched to case subjects by age and sex, and to assess NO signaling, endothelial function and exercise capacity in Fontan subjects after 4 weeks of oral vitamin C (or placebo) therapy. These results have particular importance because improving the endothelial response in Fontan patients has the potential to reduce the risk of developing congestive heart failure and improve exercise capacity. Furthermore, assessing endothelial function and the effects of therapies aimed at improving vascular health may be generalizable to many other chronic pediatric conditions associated with increased cardiovascular risk such as obesity, diabetes mellitus, and hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Dietary Supplement: Vitamin CHigh-dose Vitamin C in 4 age-based doses will be given in two-daily doses for four weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo will be given in two-daily doses for four weeks |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 8-25 years of age
- Fontan-palliated patient
Key exclusion criteria (10 listed)
- New York Heart Association (NYHA) classes III or IV
- Diabetes mellitus
- Family history of premature coronary artery disease
- Use of Sildenafil or other pulmonary artery vasodilators
- Prior cardiac arrest (outside the first 24-hours postoperatively)
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 CHigh-dose Vitamin C will be administered in 4 age-based dosing groups | Dietary supplement | Vitamin C |
| PlaceboPlacebo will be administered twice daily for four weeks | Dietary supplement | Placebo |
Primary outcome
Change in peak oxygen consumption (from baseline to post-study drug testing)
Time frame: 4 weeks
6 secondary outcomes
Oxygen Pulse
Time frame: 4 weeks
Peak Work
Time frame: 4 weeks
Endo-PAT score
Time frame: 4 weeks
Framingham Modified Endothelial Function Score
Time frame: 4 weeks
PedsQL 4.0 - quality of life assessment
Time frame: 4 weeks
BNP
Time frame: 4 weeks
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 1 Jun 2017.
- Results publication: PubMed 21600541Goldstein BH, Golbus JR, Sandelin AM, Warnke N, Gooding L, King KK, Donohue JE, Gurney JG, Goldberg CS, Rocchini AP, Charpie JR. Usefulness of peripheral vascular function to predict functional health status in patients with Fontan circulation. Am J Cardiol. 2011 Aug 1;108(3):428-34. doi: 10.1016/j.amjcard.2011.03.064. Epub 2011 May 19.
- Derived from this study: PubMed 22176653Goldstein BH, Sandelin AM, Golbus JR, Warnke N, Gooding L, King KK, Donohue JE, Yu S, Gurney JG, Goldberg CS, Rocchini AP, Charpie JR. Impact of vitamin C on endothelial function and exercise capacity in patients with a Fontan circulation. Congenit Heart Dis. 2012 May-Jun;7(3):226-34. doi: 10.1111/j.1747-0803.2011.00605.x. Epub 2011 Dec 18.
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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.
John R Charpie, MD study director
University of Michigan
Bryan H Goldstein, MD principal investigator
University of Michigan
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 Fontan Procedure and Hypoplastic Left Heart Syndrome, run by University of Michigan at 1 site in United States.
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 2 inclusion and 10 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 1 Jun 2017. 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 United States. 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 peak oxygen consumption (from baseline to post-study drug testing) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974025, which also lists 2 linked publications.
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 1 Jun 2017.