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Cardiovascular DiseasesPhase 3HARTNCT00018005

A Self-Management Intervention for Mild to Moderate Heart Failure

A Phase 3 study testing Self-Management in people with Cardiovascular Diseases and Heart Diseases, run by Lynda Powell, PhD, MEd at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure. Read more about this study

Who is it for?
Any age
What is being tested?
Self-Management
How many people
902 participants
Where
1 siteUnited States
Study dates
Jun 2001to Jun 2007
Phase
Phase 3
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • NYHA classification of II or III
  • LVEF of 40% or less

Who cannot join

  • Uncertain 12-month prognosis
  • Potential cardiac transplant within 1 year of study entry
  • Severe aortic stenosis
  • Uncontrolled ventricular tachycardia
  • Non-cardiac causes of heart failure symptoms (i.e., peripheral vascular disease, chronic obstructive pulmonary disease, and arthritis)
  • Major psychiatric co-morbidity
  • Unstable angina, myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 1 month prior to study entry

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rush-Presbyterian-St. Lukes Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Heart Failure Adherence and Retention Trial (HART)

This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure.

Read the detailed description

BACKGROUND:

Heart failure is a major disabling disease for American adults, affecting an estimated 4.9 million individuals. Heart failure is associated with enormous health care expenditures. This is because it is a progressive chronic condition that is characterized by disabling symptoms that limit independence and result in multiple hospitalizations and referrals to long-term care. The emergence of heart failure as a major public health problem is related to the unintended result of both an aging population and the success in reducing mortality from cardiovascular disease. Non-adherence to medications is a key problem in the treatment of heart failure, with adherence rates ranging from 20% to 90%. There is a clear need, therefore, to develop interventions that improve adherence in patients with heart failure.

DESIGN NARRATIVE:

This is a single-site, partially blinded, randomized clinical trial of 900 patients with systolic or diastolic dysfunction, and New York Heart Association (NYHA) functional class II or III. Patients will be recruited over a period of 2 years from seven hospitals. Patients will be randomly assigned to either a SM intervention or attention control. The SM group will meet 18 times for 2 hours over 1 year. These group sessions will teach patients how to use five basic self-management skills (self-monitoring, environmental restructuring, social support, cognitive restructuring, and the relaxation response) to help build self-efficacy and maintain it after the treatment has been discontinued. The attention control arm will consist of an educational intervention which includes 18 mailings of the American Heart Association Tip Sheets over the course of the first year, plus a telephone follow-up with the patient after each mailing to check receipt and comprehension of the Tip Sheet, and to address any questions about the Tip Sheet. Treatment effects will be evaluated using the primary outcome of hospitalization for heart failure or death, and the secondary outcomes of progression of heart failure, quality of life, and health care costs. Potential mediators of effectiveness will include improved adherence and improved psychosocial function.

Being tested
Self-Management, attention control
Keywords
Heart Failure, Self-Management, Behavioral Clinical Trial
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-ManagementBehavioural

    18 in-person group sessions providing self-management training.

  • attention controlOther

    18 educational mailings follow by a a telephone call.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time until all-cause death or heart-failure hospitalization

    This is a composite outcome, measuring time from randomization to occurrence of death due to any cause or a hospitalization that is adjudicated to be due to heart-failure, among participants who experience either (or both) of these events. Only the first occurrence of either of these events is considered.

    Measured: Measured over the two years of study follow-up.

Secondary outcomes (4)

  1. Progression of heart failure

    Measured using change in NYHA Class and Six-Minute Walk distance, from baseline.

    Measured: Measured over the two years of study follow-up

  2. Quality of life

    Measured using self-report heart-failure-specific quality of life scales.

    Measured: Measured over the two years of study follow-up

  3. Health care costs

    Measured: Measured over the two years of study follow-up

  4. Time until all-cause death or all-cause hospitalization

    This is a composite outcome, measuring time from randomization to occurrence of death due to any cause or hospitalization for any reason, among participants who experience either (or both) of these events. Only the first occurrence of either of these events is considered.

    Measured: Measured over the two years of study follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2001 (estimated)
  2. Study startJun 2001
  3. Study completionJun 2007

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00018005
Sponsor's protocol ID
137
Other IDs
R01HL065547
Acronym
HART
Status last verified
Oct 2012
First submitted
26 Jun 2001
Last updated
22 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Doukky R, Mangla A, Ibrahim Z, Poulin MF, Avery E, Collado FM, Kaplan J, Richardson D, Powell LH. Impact of Physical Inactivity on Mortality in Patients With Heart Failure. Am J Cardiol. 2016 Apr 1;117(7):1135-43. doi: 10.1016/j.amjcard.2015.12.060. Epub 2016 Jan 18.

    PubMed 26853954

  • Doukky R, Avery E, Mangla A, Collado FM, Ibrahim Z, Poulin MF, Richardson D, Powell LH. Impact of Dietary Sodium Restriction on Heart Failure Outcomes. JACC Heart Fail. 2016 Jan;4(1):24-35. doi: 10.1016/j.jchf.2015.08.007.

    PubMed 26738949

  • Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.

    PubMed 20858878

  • Powell LH, Calvin JE Jr, Mendes de Leon CF, Richardson D, Grady KL, Flynn KJ, Rucker-Whitaker CS, Janssen I, Kravitz G, Eaton C; Heart Failure Adherence and Retention Trial Investigators. The Heart Failure Adherence and Retention Trial (HART): design and rationale. Am Heart J. 2008 Sep;156(3):452-60. doi: 10.1016/j.ahj.2008.05.011.

    PubMed 18760125

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Self-Management in people with Cardiovascular Diseases and Heart Diseases, run by Lynda Powell, PhD, MEd 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 7 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 22 Oct 2012. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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.

What does the primary outcome measure?

Time until all-cause death or heart-failure hospitalization (time frame: Measured over the two years of study follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00018005, which also lists 4 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 22 Oct 2012.

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