Congestive Heart FailurePhase 1NCT00344734
Effects of Acute L-NMMA Treatment on Renal Hemodynamics and Vasoactive Hormones in Patients With Congestive Heart Failure
A Phase 1 study testing Ng-monomethyl-L-arginine (drug) in people with Congestive Heart Failure, run by Regional Hospital Holstebro.
Trial summary
The study tests the hypothesis that nitric oxide availability is changed in congestive heart failure with regard to the regulation of renal hemodynamics, renal sodium excretion and release of vasoactive hormones. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Ng-monomethyl-L-arginine (drug)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy controls
- Age 20 to 60 years
- Both men and women
- Weight below 100 kg
- Normal clinical examination and laboratory screening
- Fertile women only if using contraception
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- Informed consent according to the regulations of the local ethics committee
- Heart failure
- Both men and women
- Age 20 to 75 years
- Patients with heart failure in NYHA group II-III. Heart failure must be derived from ischaemic heart disease or dilated cardiomyopathy. Diagnosis must be verified by history and echocardiography or isotope cardiography.
- ejection fraction < 0.40
- P-creatinin < 250 µmol/L
- Fertile women only if using contraception
- Informed consent according to the regulations of the local ethics committee
Who cannot join
- Healthy controls
- History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
- Current medication
- Drugs or alcohol abuse
- Pregnancy
- Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
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- Donation of blood less than 1 month before the experiments
- Heart failure
- Cardiac valvular disease with stenosis
- Significant cardiac arrythmia
- Myocardial infarction, PTCA or by-pass surgery less than 3 months before the study
- Diseases of the lever, kidneys, lungs or endocrine organs which are not secondary to congestive heart failure
- Arterial hypertension
- Neoplastic disease
- Cerebrovascular insult
- Treatment with ACE-inhibitors or nitrates which cannot be stopped 1 week before study
About this study
Official title: Effects of Acute L-NMMA Treatment on Renal Hemodynamics, Sodium and Water Excretion and Plasma Levels of Vasoactive Hormones in Patients With Congestive Heart Failure and Healthy Controls
The study tests the hypothesis that nitric oxide availability is changed in congestive heart failure with regard to the regulation of renal hemodynamics, renal sodium excretion and release of vasoactive hormones. The study tests these hypotheses by comparing the effects of systemic nitric oxide inhibition with L-NMMA in congestive heart failure patients with healthy subjects on renal hemodynamics, blood pressure and plasma levels of vasoactive hormones.
Read the detailed description
The purpose of the study is to investigate the effects of systemic treatment with Ng-monomethyl-l-arginine in congestive heart failure and healthy controls on:
- glomerular filtration rate and renal plasma flow
- blood pressure and heart rate
- plasma levels of vasoactive hormones
- lithium clearance
The study is randomized and placebo controlled
- Conditions
- Congestive Heart Failure
- Being tested
- Ng-monomethyl-L-arginine (drug)
- Keywords
- Nitric oxide, Renal hemodynamics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ng-monomethyl-L-arginine (drug)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Jesper N Bech, MD, Ph.D., Principal investigator, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, DenmarkErling B Pedersen, Professor, Study chair, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344734
- Sponsor's protocol ID
- MED.RES.HOS.1997.03.JNB
- Status last verified
- Jun 2006
- First submitted
- 24 Jun 2006
- Last updated
- 27 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute L-NMMA Treatment on Renal Hemodynamics, Sodium and Water Excretion and Plasma Levels of Vasoactive Hormones in Patients With Congestive Heart Failure and Healthy Controls
- ClinicalTrials.gov ID
- NCT00344734
- Acronym / sponsor ID
- MED.RES.HOS.1997.03.JNB
- Conditions
- Congestive Heart Failure
- Keywords
- Nitric oxide, Renal hemodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- First posted
- 27 Jun 2006 (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 study tests the hypothesis that nitric oxide availability is changed in congestive heart failure with regard to the regulation of renal hemodynamics, renal sodium excretion and release of vasoactive hormones. The study tests these hypotheses by comparing the effects of systemic nitric oxide inhibition with L-NMMA in congestive heart failure patients with healthy subjects on renal hemodynamics, blood pressure and plasma levels of vasoactive hormones.
Detailed description
The purpose of the study is to investigate the effects of systemic treatment with Ng-monomethyl-l-arginine in congestive heart failure and healthy controls on:
- glomerular filtration rate and renal plasma flow
- blood pressure and heart rate
- plasma levels of vasoactive hormones
- lithium clearance
The study is randomized and placebo controlled
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy controls
- Age 20 to 60 years
- Both men and women
- Weight below 100 kg
- Normal clinical examination and laboratory screening
Key exclusion criteria (16 listed)
- Healthy controls
- History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
- Current medication
- Drugs or alcohol abuse
- Pregnancy
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 |
|---|---|---|
| Ng-monomethyl-L-arginine (drug) | Drug | – |
Primary outcome
Not reported in the source record.
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 27 Jun 2006.
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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.
Jesper N Bech, MD, Ph.D. principal investigator
Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Erling B Pedersen, Professor study chair
Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ng-monomethyl-L-arginine (drug) in people with Congestive Heart Failure, run by Regional Hospital Holstebro.
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 15 inclusion and 16 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 27 Jun 2006. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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.
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 27 Jun 2006.