Heart FailurePhase 4NCT00491907
Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure
A Phase 4 study testing folic acid 5mg/day in people with Heart Failure, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- folic acid 5mg/day
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2004to May 2007
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure (min. NYHA ll, LVEF <50%)
- Not smokers
- Written informed consent
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- folic acid 5mg/day
- Keywords
- folic acid, endothelial function, baroreceptor function, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acid 5mg/dayDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in endothelial function
Measured: 1 month
change in baroreceptor function
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startOct 2004
- Study completionMay 2007
Why it stopped: recruitment is finished
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 University of ZurichThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Georg Noll, MD, Principal investigator, Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491907
- Sponsor's protocol ID
- FolicAcid881
- Status last verified
- Oct 2007
- First submitted
- 25 Jun 2007
- Last updated
- 2 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00491907
- Acronym / sponsor ID
- FolicAcid881
- Conditions
- Heart Failure
- Keywords
- folic acid, endothelial function, baroreceptor function, heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment is finished
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- May 2007 (actual)
- First posted
- 26 Jun 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heart failure (min. NYHA ll, LVEF <50%)
- Not smokers
- Written informed consent
Key exclusion criteria (8 listed)
- Unstable heart failure
- Smoking
- Unstabile Angina Pectoris
- Endocrinologic disease such as Diabetes mellitus, Hypo- und Hyperthyroidism
- Alcohol abuse
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 |
|---|---|---|
| folic acid 5mg/day | Drug | – |
Primary outcome
change in endothelial function
Time frame: 1 month
change in baroreceptor function
Time frame: 1 month
Results and safety
The study was stopped early (reason given: recruitment is finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2007.
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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.
Georg Noll, MD principal investigator
Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing folic acid 5mg/day in people with Heart Failure, run by University of Zurich.
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 8 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: stopped early, as of the sponsor's last update on 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment is finished). Results are not available in the source record.
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 endothelial function (time frame: 1 month). The study lists 2 primary outcomes in all. 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 2 Oct 2007.