Congestive Heart FailureNCT00782782
Vascular Sensitivity to Adrenergic Agonists in Patients With CHF and in Healthy Subjects
An observational study of Congestive Heart Failure, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular responses. The aim of this study is to characterize these differences. Our hypothesis is, that there are differences in vascular responses between healthy subjects and patients with CHF. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Dec 2011
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with congestive heart failure NYHA I-II and healthy subjects
Who may be able to join
- Patients with congestive heart failure NYHA I-II
- Stable clinical condition
Who cannot join
- Resting systolic blood pressure < 100
- Resting heart rate < 50
- Hypersensitivity to dexmedetomidine, phenylephrine, isoproterenol, terbutaline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Medications on Vascular Response in Patients With CHF and in Healthy Subjects
Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular responses. The aim of this study is to characterize these differences. Our hypothesis is, that there are differences in vascular responses between healthy subjects and patients with CHF.
- Conditions
- Congestive Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular sensitivity (ED50) and response (Emax) to dexmedetomidine, phenylephrine, isoproterenol and terbutaline
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2011 (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.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Mordechai Muszkat, Principal investigator, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782782
- Sponsor's protocol ID
- 366-28.12.07
- Status last verified
- Oct 2008
- First submitted
- 26 Oct 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medications on Vascular Response in Patients With CHF and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00782782
- Acronym / sponsor ID
- 366-28.12.07
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 31 Oct 2008 (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.
Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular responses. The aim of this study is to characterize these differences. Our hypothesis is, that there are differences in vascular responses between healthy subjects and patients with CHF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with congestive heart failure NYHA I-II and healthy subjects
Key inclusion criteria (2 listed)
- Patients with congestive heart failure NYHA I-II
- Stable clinical condition
Key exclusion criteria (3 listed)
- Resting systolic blood pressure < 100
- Resting heart rate < 50
- Hypersensitivity to dexmedetomidine, phenylephrine, isoproterenol, terbutaline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vascular sensitivity (ED50) and response (Emax) to dexmedetomidine, phenylephrine, isoproterenol and terbutaline
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
Mordechai Muszkat principal investigator
Hadassah University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Hadassah Medical Organization at 1 site in Israel.
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 3 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 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 Israel. 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?
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?
vascular sensitivity (ED50) and response (Emax) to dexmedetomidine, phenylephrine, isoproterenol and terbutaline (time frame: 3 weeks). 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 Oct 2008.