Congestive Heart FailurePhase 4NCT00047775
African-American Heart Failure Trial
A Phase 4 study testing BiDil in people with Congestive Heart Failure, run by Nitromed at 7 sites in United States.
Trial summary
A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- BiDil
- How many people
- 1,100 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2001to Aug 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- African American male or female 18 years or older.
- NYHA Class 3 \& 4.
- Have either a resting LVEF less than or equal to 35% (by any method) or a resting LVIDD greater than 2.9 cm/m2 BSA (or greater than 6.5 cm) with LVEF less than 45% (by echocardiogram).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Miami International Cardiology Consultants
Aventura, Florida, 33180
Cooper Green Hospital
Birmingham, Alabama, 35233
Boston Medical Center
Boston, Massachusetts, 02118
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
Saint Vincents Hospital and Medical Center
New York, New York, 10011
Howard University Hospital
Washington D.C., District of Columbia, 20060
About this study
A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure.
Read the detailed description
The overall objective is confirmation of BiDil's Safety and Efficacy in African-American (AFA) Patients with Moderate to Severe Symptomatic Heart Failure.
- Conditions
- Congestive Heart Failure
- Being tested
- BiDil
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiDilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2002 (estimated)
- Study startMay 2001
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,100 participants
Sponsor and investigators
- Lead sponsor
- Nitromed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anne L. Taylor, M.D., Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047775
- Sponsor's protocol ID
- A-HeFT
- Status last verified
- Oct 2004
- First submitted
- 18 Oct 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Anand IS, Win S, Rector TS, Cohn JN, Taylor AL. Effect of fixed-dose combination of isosorbide dinitrate and hydralazine on all hospitalizations and on 30-day readmission rates in patients with heart failure: results from the African-American Heart Failure Trial. Circ Heart Fail. 2014 Sep;7(5):759-65. doi: 10.1161/CIRCHEARTFAILURE.114.001360. Epub 2014 Jun 26.
PubMed 24970468Mitchell JE, Tam SW, Trivedi K, Taylor AL, O'Neal W, Cohn JN, Worcel M. Atrial fibrillation and mortality in African American patients with heart failure: results from the African American Heart Failure Trial (A-HeFT). Am Heart J. 2011 Jul;162(1):154-9. doi: 10.1016/j.ahj.2011.04.022.
PubMed 21742102
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African-American Heart Failure Trial
- ClinicalTrials.gov ID
- NCT00047775
- Acronym / sponsor ID
- A-HeFT
- Conditions
- Congestive Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants
- Lead sponsor
- NitromedIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Study completion
- Aug 2004
- First posted
- 21 Oct 2002 (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.
A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure.
Detailed description
The overall objective is confirmation of BiDil's Safety and Efficacy in African-American (AFA) Patients with Moderate to Severe Symptomatic Heart Failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BiDil | 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 24 Jun 2005.
- Derived from this study: PubMed 24970468Anand IS, Win S, Rector TS, Cohn JN, Taylor AL. Effect of fixed-dose combination of isosorbide dinitrate and hydralazine on all hospitalizations and on 30-day readmission rates in patients with heart failure: results from the African-American Heart Failure Trial. Circ Heart Fail. 2014 Sep;7(5):759-65. doi: 10.1161/CIRCHEARTFAILURE.114.001360. Epub 2014 Jun 26.
- Derived from this study: PubMed 21742102Mitchell JE, Tam SW, Trivedi K, Taylor AL, O'Neal W, Cohn JN, Worcel M. Atrial fibrillation and mortality in African American patients with heart failure: results from the African American Heart Failure Trial (A-HeFT). Am Heart J. 2011 Jul;162(1):154-9. doi: 10.1016/j.ahj.2011.04.022.
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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.
Anne L. Taylor, M.D. study chair
University of Minnesota
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BiDil in people with Congestive Heart Failure, run by Nitromed at 7 sites 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?
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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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 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?
On the ClinicalTrials.gov record for NCT00047775, which also lists 2 linked publications.
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 24 Jun 2005.