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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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United States of America
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Kansas
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State/province [243] 0 0
Monastir
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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
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United Arab Emirates
State/province [256] 0 0
Dubai
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United Kingdom
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Birmingham
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United Kingdom
State/province [258] 0 0
Cleveland
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United Kingdom
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West Yorkshire
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United Kingdom
State/province [260] 0 0
Yorkshire
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United Kingdom
State/province [261] 0 0
Chesterfield
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State/province [262] 0 0
Telford
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State/province [263] 0 0
Uxbridge
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State/province [264] 0 0
Wakefield
Country [265] 0 0
United Kingdom
State/province [265] 0 0
York
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Vietnam
State/province [266] 0 0
Ho Chi Minh City
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT02595814
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.
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
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Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02595814