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BLITZ Heart Failure (BLITZ-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661060
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Heart Care Foundation

Study Description
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Brief Summary:
To evaluate if Italian Cardiologists are treating Heart Failure (HF) patients according to International guidelines and if a structured educational program can improved their adherence.

Condition or disease
Heart Failure

Detailed Description:
Multicentre, cross-sectional, prospective, non-interventional, observational study designed to evaluate the level of adherence to current ESC guidelines recommendations in both acute and chronic HF patients enrolled in each participating center and to verify if a specific HF educational intervention composed by an educational web based program of data collection and face to face meetings is able to improve adherence to guidelines recommendations evaluated during a second enrollment period.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 7569 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: BLITZ Heart Failure
Actual Study Start Date : March 8, 2017
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : July 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Adherence to current guideline [ Time Frame: Enrollment ]
    To assess number of patients managed and treated following the 2016 ESC Heart Failure Gudelines (acute HF, chronic HFrEF, chronic HFmrEF, chronic HFpEF).

  2. Patients managed and treated following International Guideline [ Time Frame: 24 months ]
    Patients treatment in phase 1 versus phase 3


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 12 months Follow-up ]
    Death from all-causes, for cardiovascular causes, for HF

  2. Morbidity [ Time Frame: 12 months Follow-up ]
    Hospital admissions from all-causes, for cardiovascular causes, for HF

  3. Indication to heart failure device implantation [ Time Frame: Enrollement ]
    The rate of patients with chronic HFrEF with an indication to ICD and/or CRT planned in clinical practice

  4. Prescription rate of disease modifying drugs [ Time Frame: Enrollment ]
    The rate of patients with HFrEF receiving all the drugs recommended by current guidelines: ACE-Is/ARBs, betablockers and MRAs, in the absence of specific contraindications/intolerance.

  5. Oral anticoagulation prescription in patients with AF [ Time Frame: Enrollment ]
    Rate of patients treated with oral anticoagulants in case of AF

  6. Use of ARNI [ Time Frame: Enrollment ]
    The rate of implementation of a new drug approach (ARNI) for patients with HF and EF ≤35%

  7. Creatinine and EF evaluation [ Time Frame: Enrollment ]
    The rate of CHF patients with an available measure of EF and of creatinine.


Eligibility Criteria
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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:   Non-Probability Sample
Study Population
Hospitalized and ambulatory heart failure patients admitted to or evaluated in Italian Hospitals
Criteria

Inclusion Criteria:

  • All consecutive patients with chronic HF and those admitted for acute (de novo) or worsening chronic HF.
  • Chronic HF: any NYHA class (I-IV).
  • Acute HF Only patients in NYHA class III or IV, or with pulmonary edema or cardiogenic shock for whom an IV therapy specific for HF (diuretic, vasodilators, vasopressors) is administered.
  • Any gender.
  • Any etiology of HF.
  • Any level of EF.
  • Written informed consent.

Exclusion Criteria:

  • - Age <18 years.
  • Inclusion in registries or trials that can influence, by protocol, the clinical management of patients.
  • Patients already enrolled in the BLITZ HF (by another participating centre or in the first enrollment period).
Contacts and Locations
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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): NCT03661060


Locations
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Sponsors and Collaborators
Heart Care Foundation
More Information
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Additional Information:

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Responsible Party: Heart Care Foundation
ClinicalTrials.gov Identifier: NCT03661060    
Other Study ID Numbers: K15
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heart Care Foundation:
Acute Heart Failure
Chronic Heart Failure
Guideline adherence
Clinical registry
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases