NCT02946476

Brief Summary

To better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure patients with reduced ejection fraction (HFREF) and heart failure patients with preserved ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted hazard ratio (HR) and the population attributable risk were used to compare the contributions of 15 noncardiac comorbidities to adverse outcome. The comorbidities that contributed to high attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and peripheral artery disease. These findings were similar for HFrEF and HFpEF groups. Interaction analysis confirmed similar results.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

4.1 years

First QC Date

October 25, 2016

Last Update Submit

October 25, 2016

Conditions

Heart Failure, DiastolicHeart Failure, Systolic

Outcome Measures

Primary Outcomes (1)

  • overall mortality

    2 years

Secondary Outcomes (3)

  • First all-cause hospitalization

    2 years

  • Heart Failure hospitalization

    2 years

  • noncardiovascular hospitalization

    2 years

Study Arms (2)

HFrEF

patients with heart failure and reduced ejection fraction

Other: prognostic impact of non cardiac comorbidities

HFpEF

patients with heart failure and preserved ejection fraction

Other: prognostic impact of non cardiac comorbidities

Interventions

prognostic impact of non cardiac comorbiditiesOTHER
HFpEFHFrEF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We studied all consecutive heart failure patients with diagnostic codes presenting clinical findings compatible with heart failure

You may qualify if:

  • All consecutive heart failure patients with left ventricular ejction fraction available before or within 3 months from the index visit

You may not qualify if:

  • We excluded all patients who had severe primary left-sided valvular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure, DiastolicHeart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 27, 2016

Study Start

November 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

October 27, 2016

Record last verified: 2016-10