Heart Failure, CongestiveNCT00132106
The Effect of Alfa-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure
A study testing phentolamine in people with Heart Failure, Congestive, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The activity of the sympathetic nervous system seems to influence the uptake (and handling) of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is increased seem to inhibit/reduce forearm glucose uptake. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- phentolamine
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to not given
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- 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 18-75 years
Who cannot join
- Alfa-blockers, or beta-blockers with alfa-blocking activity (carvedilol)
- Tricyclic antidepressants
- Warfarin derivatives (acetylic salicylic acid and clopidogrel are allowed)
- Hospitalisation in 6 weeks prior to the study
- Any change in medication in 6 weeks prior to the study
- Unstable angina
Show all 10Show fewer
- Orthopnoea
- Known chronic disease of the autonomic nervous system
- Diabetes mellitus
- Oedema of the lower extremities, complicating the insertion of a venous catheter in a vein on the foot
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
Marc ER Gomes, MD, 31-24-3614533/3616550, m.gomes@cardio.umcn.nl
Marc ER Gomes, MD
About this study
Official title: The Effect of a-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure
The activity of the sympathetic nervous system seems to influence the uptake (and handling) of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is increased seem to inhibit/reduce forearm glucose uptake. Inversely a decrease in sympathetic activity seems to increase glucose uptake. This study analyzes the effect of alfa-adrenergic receptor blockade (counteracting sympathetic influence) on insulin-stimulated forearm glucose uptake in patients with increased sympathetic activity (patients with chronic heart failure).
- Conditions
- Heart Failure, Congestive
- Being tested
- phentolamine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phentolamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glucose uptake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132106
- Sponsor's protocol ID
- CHFALFA
- Status last verified
- Aug 2007
- First submitted
- 18 Aug 2005
- Last updated
- 31 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00132106
- Acronym / sponsor ID
- CHFALFA
- Conditions
- Heart Failure, Congestive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Aug 2005
- First posted
- 19 Aug 2005 (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 activity of the sympathetic nervous system seems to influence the uptake (and handling) of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is increased seem to inhibit/reduce forearm glucose uptake. Inversely a decrease in sympathetic activity seems to increase glucose uptake. This study analyzes the effect of alfa-adrenergic receptor blockade (counteracting sympathetic influence) on insulin-stimulated forearm glucose uptake in patients with increased sympathetic activity (patients with chronic heart failure).
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- 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 18-75 years
Key exclusion criteria (10 listed)
- Alfa-blockers, or beta-blockers with alfa-blocking activity (carvedilol)
- Tricyclic antidepressants
- Warfarin derivatives (acetylic salicylic acid and clopidogrel are allowed)
- Hospitalisation in 6 weeks prior to the study
- Any change in medication in 6 weeks prior to the study
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 |
|---|---|---|
| phentolamine | Drug | – |
Primary outcome
change in glucose uptake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.
Cees J Tack, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phentolamine in people with Heart Failure, Congestive, 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 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: status not confirmed, as of the sponsor's last update on 31 Aug 2007. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc E.R. Gomes, MD (+31-24-3614533/3616550, m.gomes@cardio.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in glucose uptake. 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 31 Aug 2007.