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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02595814
Registration number
NCT02595814
Ethics application status
Date submitted
13/10/2015
Date registered
3/11/2015
Date last updated
14/11/2018
Titles & IDs
Public title
Global Non-interventional Heart Failure Disease Registry
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Scientific title
International Registry to Assess mEdical Practice With lOngitudinal obseRvation for Treatment of Heart Failure
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Secondary ID [1]
0
0
CRPORTHF
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Universal Trial Number (UTN)
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Trial acronym
REPORT-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Heart Failure
0
0
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Condition category
Condition code
Cardiovascular
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0
0
0
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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
Number of patients with different characteristics of heart faliure (HF) at hospitalization
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Assessment method [1]
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Timepoint [1]
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From admission to discharge of the patient's index hospitalization (minimum 24 hours)
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Primary outcome [2]
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Percentage of patients who die during the index hospitalization
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Assessment method [2]
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0
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Timepoint [2]
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From admission to discharge of the patient's index hospitalization (minimum 24 hours)
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Primary outcome [3]
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0
Percentage of patients who die during the follow-up period post-discharge
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Assessment method [3]
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0
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Timepoint [3]
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up to 3 years
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Primary outcome [4]
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Percentage of patients who are re-hospitalized by primary re-hospitalization reason (Cardiovascular and non-Cardiovascular)
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Assessment method [4]
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0
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Timepoint [4]
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up to 3 years
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Primary outcome [5]
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Number of patients with different characteristics of post-discharge patient management
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Assessment method [5]
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0
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Timepoint [5]
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up to 3 years
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Primary outcome [6]
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Healthcare Resource Utilization assessed by number of patients with re-hospitalizations
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Assessment method [6]
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0
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Timepoint [6]
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up to 3 years
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Secondary outcome [1]
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Health-related Quality of life (HRQoL) based on patient reported data as measured by EQ-5D and the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires
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Assessment method [1]
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0
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Timepoint [1]
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up to 3 years
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Secondary outcome [2]
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Caregiver burden based on Caregiver Burden Questionnaire -Heart Failure (CBQ-HF) and Work Productivity and Activity Impairment (WPAI) questionnaires
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Assessment method [2]
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0
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Timepoint [2]
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up to 3 years
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Secondary outcome [3]
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Correlation ratio between practice patterns and outcomes
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Assessment method [3]
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Timepoint [3]
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up to 3 years
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Eligibility
Key inclusion criteria
Patients at least 18 years old, or older for those countries where the adult age is above 18 years of age, hospitalized with a primary diagnosis of acute heart failure.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1-Concomitant participation in any/a clinical trial with any investigational treatment (for any sponsor).
2. Use of investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2018
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Sample size
Target
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Accrual to date
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Final
18805
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Novartis Investigative Site - Gosford
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Recruitment hospital [2]
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Novartis Investigative Site - Auchenflower
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Novartis Investigative Site - Greenslopes
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Recruitment hospital [4]
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Novartis Investigative Site - Bedford Park
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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4120 - Greenslopes
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Recruitment postcode(s) [4]
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SA 5042 - Bedford Park
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Recruitment outside Australia
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Funding & Sponsors
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Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.
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Trial website
https://clinicaltrials.gov/study/NCT02595814
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Trial related presentations / publications
Filippatos G, Khan SS, Ambrosy AP, Cleland JG, Collins SP, Lam CS, Angermann CE, Ertl G, Dahlstrom U, Hu D, Dickstein K, Perrone SV, Ghadanfar M, Bermann G, Noe A, Schweizer A, Maier T, Gheorghiade M. International REgistry to assess medical Practice with lOngitudinal obseRvation for Treatment of Heart Failure (REPORT-HF): rationale for and design of a global registry. Eur J Heart Fail. 2015 May;17(5):527-33. doi: 10.1002/ejhf.262. Epub 2015 Mar 10.
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https://clinicaltrials.gov/study/NCT02595814
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