Heart failure with preserved ejection fraction(HFpEF) is the main type of heart failure(HF) and accounts for about 50% of HF. The incidence and prevalence of HFpEF continue to grow as the population ages, lifestyle changes, and the burden of obesity and cardiac metabolic diseases increases. HFpEF has complex pathophysiological mechanisms different from heart failure with reduced ejection fraction and the medical community lacks sufficient understanding and treatment methods for HFpEF. As a result, HFpEF is currently considered to be the largest unmet medical need in the cardiovascular field.
The number of clinical trials exploring effective treatment strategies for HFpEF continues to grow. However, there are large differences among the outcome measures reported in these clinical trials, resulting in a lack of comparability between the study results. Developing a core outcome set (COS) is an effective method to solve the above problem.
Some core outcome sets for HF already exist. However, HFpEF is a relatively new disease concept isolated from traditional HF concept and has different pathophysiological mechanisms and clinical features from other types of HF. Therefore, the existing core outcome sets within the general context of HF are not exactly applicable to HFpEF. Selection of the optimal outcomes should take into account the unique differences of HFpEF.
At present, no cos has been established for HFpEF, a subtype of heart failure, so this study aims to develop a cos suitable for clinical trials of HFpEF.
Guoju Dong is the principal investigator.
Affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Contributors: National Clinical Research Center of Cardiovascular Diseases of Chinese Medicine, Cardiovascular Disease Professional Committee of the Chinese Research Society for the Integration of Traditional Chinese and Western Medicine
Disease Category: Heart & circulation
Disease Name: Heart failure with preserved ejection fraction
Age Range: 0 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Systematic review
Firstly, randomized controlled trails of heart failure with preserved ejection fraction will be obtained from systematically searching the following English and Chinese databases: PubMed, Embase, Cochrane Library, Web of Science, Clinical Trials, CNKI, VIP, Wanfang, CBM and ChiCTR. Two researchers will independently screen literatures, extract basic information and outcome measures. Then, semi-structured interviews will be conducted with doctors and patients to collect clinically important outcomes. Outcome measures obtained above will be combined to construct a outcome measure pool. Then, outcome measures in the pool will be classified according to their functional attributes and domains will be determined. Preliminary consensus will be reached on the importance of each candidate outcome measure through the Delphi process. Finally, the core outcome set for clinical trials in heart failure with preserved ejection fraction will be discussed and finalized through expert consensus meeting.