Heart FailureNCT00585455
Vascular Effects of Sertraline in Heart Failure
An observational study of Heart Failure and Depression, run by Yale University at 1 site in United States.
Trial summary
To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, Depression
- What is being tested?
- sertraline
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jul 2009
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic heart failure patients with concomitant depression
Who may be able to join
- Chronic heart failure with LVEF<40%, age >21 years
- Depression requiring medical treatment with sertraline
Who cannot join
- Known intolerance of sertraline
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Effects of Chronic Sertraline Hydrochloride Administration on Vascular Endothelial and Autonomic Function in Patients With Chronic Heart Failure
To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression
- Conditions
- Heart Failure, Depression
- Being tested
- sertraline
- Keywords
- vascular endothelium, nitric oxide, depression, heart failure, vascular biology
- Medical subject headings
- Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
open label 25-50 mg daily as tolerated
| Study group | Role | What they receive |
|---|---|---|
| A | Chronic heart failure patients with concomitant depression Receives: Drug: sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: PI change in institution
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 Yale UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Stuart Katz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585455
- Sponsor's protocol ID
- 0410027131
- Status last verified
- Jul 2009
- First submitted
- 22 Dec 2007
- Last updated
- 23 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Sertraline Hydrochloride Administration on Vascular Endothelial and Autonomic Function in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00585455
- Acronym / sponsor ID
- 0410027131
- Conditions
- Heart Failure, Depression
- Keywords
- vascular endothelium, nitric oxide, depression, heart failure, vascular biology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI change in institution
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Jan 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.
To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: sertralineChronic heart failure patients with concomitant depression |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic heart failure patients with concomitant depression
Key inclusion criteria (2 listed)
- Chronic heart failure with LVEF<40%, age >21 years
- Depression requiring medical treatment with sertraline
Key exclusion criteria (1 listed)
- Known intolerance of sertraline
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 |
|---|---|---|
| sertralineopen label 25-50 mg daily as tolerated | Drug | A |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: 2 months
Results and safety
The study was stopped early (reason given: PI change in institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2009.
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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.
Stuart Katz, MD principal investigator
Yale University
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 Heart Failure and Depression, run by Yale University 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 1 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 23 Jul 2009. 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. 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 was stopped early (reason given: PI change in institution). 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?
Brachial artery flow-mediated dilation (time frame: 2 months). 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 23 Jul 2009.