Prognostic Impact of Noncardiac Comorbidities in Heart Failure Patients

Heart Failure, Systolic Clinical Trial

— NCC-HF  

Official title:

Prevalence and Prognostic Impact of Noncardiac Comorbidities in Heart Failure Outpatients With Preserved and Reduced Ejection Fraction: A Community-Based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946476
• Other study ID #: OMTrieste
• 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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic

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