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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02946476
Other study ID # OMTrieste
Secondary ID
Status Completed
Phase N/A
First received October 25, 2016
Last updated October 25, 2016
Start date November 2009
Est. completion date December 2014

Study information

Verified date October 2016
Source Ospedale Maggiore Di Trieste
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2314
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Intervention

Other:
prognostic impact of non cardiac comorbidities


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ospedale Maggiore Di Trieste

Outcome

Type Measure Description Time frame Safety issue
Primary overall mortality 2 years Yes
Secondary First all-cause hospitalization 2 years Yes
Secondary Heart Failure hospitalization 2 years Yes
Secondary noncardiovascular hospitalization 2 years Yes
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