Assessing the profile of CHF patients with redUced ejection fraction being managed in the pRimary care sectOr across GeRmany as well as the phArmacologic treatment these HF patients receive (AURORA-HF)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39319
• EU PAS number:
  EUPAS12912
• Study ID:
  39319
• Official title and acronym:
  Assessing the profile of CHF patients with redUced ejection fraction being managed in the pRimary care sectOr across GeRmany as well as the phArmacologic treatment these HF patients receive (AURORA-HF)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The non-interventional AURORA-HF study is conducted in cooperation with General Practitioners (GPs) who are treating chronic heart failure (CHF) patients in Germany. Amendment 01 of the protocol resulted in a strong reduction in the patient number and study sites. As the objectives do not address safety topics, Novartis does not expect that the trial will add knowledge on the safety of the medicinal product. Hence the trial category assessment changed from PASS to Non-PASS.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 999 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 01/02/2016

Study start date

Planned: 23/03/2016

Actual: 29/03/2016

Data analysis start date

Planned: 01/08/2019

Actual: 20/12/2019

Date of final study report

Planned: 15/07/2019

Actual: 17/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CLCZ696BDE02