Evaluation of the undertreatment and disease outcomes for patients with coexisting Heart Failure and Chronic Obstructive Pulmonary Disease

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27216
• EU PAS number:
  EUPAS12987
• Study ID:
  27216
• Official title and acronym:
  Evaluation of the undertreatment and disease outcomes for patients with coexisting Heart Failure and Chronic Obstructive Pulmonary Disease
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The objectives of this study are to assess the prevalence of comorbid diagnosed COPD and HF and to describe therapies prescribed and diagnostic tests undertaken by clinicians in real-life clinical practice for patients with COPD and/or HF. Additionally, it will evaluate the long-term respiratory and cardiovascular outcomes associated with the prescribed therapies for patients with comorbid COPD and HF. This study will be conducted using historical data from patients with COPD and/or heart failure. The prevalence of comorbid diagnosed COPD and HF will be assessed at the time of most recent data available for each patient, from all patients with a diagnosis of either COPD and/or HF. COPD and HF therapies prescribed and diagnostic tests undertaken will be considered in the year prior to most recent data available, between January 2010 to date for patients, comparing patients with comorbid COPD and HF to those with COPD alone and to those with HF alone. Cardiovascular and respiratory outcomes will be assessed for patients with comorbid COPD and HF, comparing those with adequate versus inadequate treatment for COPD/HF (according to guidelines). These outcomes will be assessed over at least one year and up to three years.
• Study status:
  Finalised

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 20/11/2015

Study start date

Actual: 05/02/2016

Date of final study report

Planned: 13/03/2017

Actual: 08/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Regulatory

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