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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
Scientific title
International Registry to Assess mEdical Practice With lOngitudinal obseRvation for Treatment of Heart Failure
Secondary ID [1] 0 0
CRPORTHF
Universal Trial Number (UTN)
Trial acronym
REPORT-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with different characteristics of heart faliure (HF) at hospitalization
Timepoint [1] 0 0
From admission to discharge of the patient's index hospitalization (minimum 24 hours)
Primary outcome [2] 0 0
Percentage of patients who die during the index hospitalization
Timepoint [2] 0 0
From admission to discharge of the patient's index hospitalization (minimum 24 hours)
Primary outcome [3] 0 0
Percentage of patients who die during the follow-up period post-discharge
Timepoint [3] 0 0
up to 3 years
Primary outcome [4] 0 0
Percentage of patients who are re-hospitalized by primary re-hospitalization reason (Cardiovascular and non-Cardiovascular)
Timepoint [4] 0 0
up to 3 years
Primary outcome [5] 0 0
Number of patients with different characteristics of post-discharge patient management
Timepoint [5] 0 0
up to 3 years
Primary outcome [6] 0 0
Healthcare Resource Utilization assessed by number of patients with re-hospitalizations
Timepoint [6] 0 0
up to 3 years
Secondary outcome [1] 0 0
Health-related Quality of life (HRQoL) based on patient reported data as measured by EQ-5D and the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires
Timepoint [1] 0 0
up to 3 years
Secondary outcome [2] 0 0
Caregiver burden based on Caregiver Burden Questionnaire -Heart Failure (CBQ-HF) and Work Productivity and Activity Impairment (WPAI) questionnaires
Timepoint [2] 0 0
up to 3 years
Secondary outcome [3] 0 0
Correlation ratio between practice patterns and outcomes
Timepoint [3] 0 0
up to 3 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2018
Sample size
Target
Accrual to date
Final
18805
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Gosford
Recruitment hospital [2] 0 0
Novartis Investigative Site - Auchenflower
Recruitment hospital [3] 0 0
Novartis Investigative Site - Greenslopes
Recruitment hospital [4] 0 0
Novartis Investigative Site - Bedford Park
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
SA 5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Louisiana
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GR
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Athens
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Glyfada
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Ioannina
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Piraeus
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Guatemala
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Guatemala City
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Leon
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Muang
Country [243] 0 0
Tunisia
State/province [243] 0 0
Monastir
Country [244] 0 0
Tunisia
State/province [244] 0 0
Sousse
Country [245] 0 0
Tunisia
State/province [245] 0 0
Tunis
Country [246] 0 0
Turkey
State/province [246] 0 0
Ankara
Country [247] 0 0
Turkey
State/province [247] 0 0
Bursa
Country [248] 0 0
Turkey
State/province [248] 0 0
Diskapi / Ankara
Country [249] 0 0
Turkey
State/province [249] 0 0
Haydarpasa/Istanbul
Country [250] 0 0
Turkey
State/province [250] 0 0
Istanbul
Country [251] 0 0
Turkey
State/province [251] 0 0
Meselik / Eskisehir
Country [252] 0 0
Turkey
State/province [252] 0 0
Pendik / Istanbul
Country [253] 0 0
Turkey
State/province [253] 0 0
Sivas
Country [254] 0 0
United Arab Emirates
State/province [254] 0 0
Abu Dhabi
Country [255] 0 0
United Arab Emirates
State/province [255] 0 0
Al Ain
Country [256] 0 0
United Arab Emirates
State/province [256] 0 0
Dubai
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Birmingham
Country [258] 0 0
United Kingdom
State/province [258] 0 0
Cleveland
Country [259] 0 0
United Kingdom
State/province [259] 0 0
West Yorkshire
Country [260] 0 0
United Kingdom
State/province [260] 0 0
Yorkshire
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Chesterfield
Country [262] 0 0
United Kingdom
State/province [262] 0 0
Telford
Country [263] 0 0
United Kingdom
State/province [263] 0 0
Uxbridge
Country [264] 0 0
United Kingdom
State/province [264] 0 0
Wakefield
Country [265] 0 0
United Kingdom
State/province [265] 0 0
York
Country [266] 0 0
Vietnam
State/province [266] 0 0
Ho Chi Minh City
Country [267] 0 0
Vietnam
State/province [267] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02595814