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Global Non-interventional Heart Failure Disease Registry (REPORT-HF)

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ClinicalTrials.gov Identifier: NCT02595814
Recruitment Status : Terminated
First Posted : November 3, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease
Acute Heart Failure

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Study Type : Observational [Patient Registry]
Actual Enrollment : 18805 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: International Registry to Assess mEdical Practice With lOngitudinal obseRvation for Treatment of Heart Failure
Actual Study Start Date : July 23, 2014
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Number of patients with different characteristics of heart faliure (HF) at hospitalization [ Time Frame: From admission to discharge of the patient's index hospitalization (minimum 24 hours) ]
  2. Percentage of patients who die during the index hospitalization [ Time Frame: From admission to discharge of the patient's index hospitalization (minimum 24 hours) ]
  3. Percentage of patients who die during the follow-up period post-discharge [ Time Frame: up to 3 years ]
  4. Percentage of patients who are re-hospitalized by primary re-hospitalization reason (Cardiovascular and non-Cardiovascular) [ Time Frame: up to 3 years ]
  5. Number of patients with different characteristics of post-discharge patient management [ Time Frame: up to 3 years ]
  6. Healthcare Resource Utilization assessed by number of patients with re-hospitalizations [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Health-related Quality of life (HRQoL) based on patient reported data as measured by EQ-5D and the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires [ Time Frame: up to 3 years ]
  2. Caregiver burden based on Caregiver Burden Questionnaire -Heart Failure (CBQ-HF) and Work Productivity and Activity Impairment (WPAI) questionnaires [ Time Frame: up to 3 years ]
  3. Correlation ratio between practice patterns and outcomes [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Enrollment of adult patients hospitalized with a primary diagnosis of acute Heart Failure (HF), i.e. new-onset (first diagnosis) HF or decompensation of chronic HF
Criteria

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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595814


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Sponsors and Collaborators
Novartis Pharmaceuticals

Additional Information:

Publications:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02595814     History of Changes
Other Study ID Numbers: CRPORTHF
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Registry
Heart failure
Hospitalized
Global
Morbidity
Mortality
Quality of life
AHF

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases