Depression and Heart Failure Disease Progression

NCT02131428 | Completed

• 1 other identifier: Pro00052933
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is the most costly diagnosis in the Medicare population. Clinical depression is strikingly common in heart failure patients, and not only diminishes their quality of life, but also is associated with a markedly increased risk of hospitalization or death. This study is designed to further our understanding of the behavioral and biological effects of depression in patients with heart failure, so that appropriate treatments can be developed.

Conditions

Heart Failure

Keywords

Heart Failure; Depression; BNP

Outcome Measures

Primary Outcomes (4)

• Time to Hospitalization or Death

  Time to hospitalization or death

  5 years

• Change in Quality of Life

  Psychosocial measures of Quality of Life

  Bi-weekly of a 4-month period, 4 months, 1 year

• Change in Self-Management Behaviors

  Health Behaviors

  Bi-weekly of a 4-month period, 4 months, 1 year

• Change in Heart Failure Disease Biomarkers

  Disease Biomarkers

  Bi-weekly of a 4-month period, 4 months, 1 year

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women aged 21 years or older with diagnosed heart failure.

You may qualify if:

• Men or women aged 21 years or older
• Heart Failure of at least 3-months duration
• Left ventricular Ejection Fraction (EF) ≤ 45% by left ventricular angiography, nuclear wall motion study, or echocardiography, Or
• Preserved ejection fraction with either: Hospitalization within the previous 12 months with management of heart failure as a major component of the care provided; or Elevated natriuretic peptide level (NT-proBNP ≥ 360 pg/ml or BNP ≥ 100 pg/ml) within 6 months of enrollment.
• Undergoing treatment with a stable medication regimen.

You may not qualify if:

• Myocardial Infarction (MI), within 1 month of enrollment
• Percutaneous Transluminal Coronary Angioplasty(PTCA), Coronary Artery Bypass Graft (CABG) within 3 month of enrollment
• HF due to correctable cause or condition such as uncorrected primary valvular disease
• Alcohol or drug abuse within 12 months
• Illness such as malignancies that are associated with a life-expectancy of \< 12 months
• Current pregnancy
• Inability to provide informed consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA are optional.

MeSH Terms

Conditions

Heart Failure; Depression

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Andrew Sherwood, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 6, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)