Copenhagen Heart Failure With Preserved Ejection Fraction

Официальное название

CoPenhagen Heart Failure With Preserved Ejection Fraction (CPH-HFpEF)

Обзор

Heart failure with preserved ejection fraction (HFpEF) has grown to become the dominant form of heart failure (HF) worldwide, in tandem with ageing of the general population and the increasing prevalence of obesity, diabetes mellitus and hypertension. In 2020, \> 70% of patients with heart failure had preserved ejection fraction. The incidence and prevalence of HFpEF has been growing by 10% every 10 years relative to HF with reduced ejection fraction (HFrEF). In 2017, the prevalence of HFpEF varied from 1% to 14% based on available data from Europe and USA. HFpEF is associated with high morbidity and mortality, and patients with HFpEF have similarly high hospitalization rates as patients with HFrEF. Hence, HFpEF poses a substantial global health challenge. Despite its prevalence, HFpEF remains undiagnosed and underrecognized, necessitating a comprehensive approach to both identification and management. Ensuring successful treatment necessitates early identification of HFpEF. Consequently, a targeted screening strategy has been devised for the identification of HFpEF patients. Given the higher prevalence of heart failure (HF) in the elderly population, testing the screening strategy is imperative to customize it to the specific needs of vulnerable patients who may be more inclined to decline participation in the screening program.

Подробное описание

The study is a prospective, observational cohort study. Using risk factors for HFpEF, the Danish National Health Registries will be used to identify up to 5000 citizens with at least one risk factor for HFpEF relying on International Classification of Diseases, 10th revision (ICD-10), medication, and biochemistry. The investigators will only recruit patients from the Capital Region of Denmark. Participants will be recruited by sending recruitment letters to a secure electronic mailbox (eBoks) linked to the patients' social security numbers.

The purpose of this study is to evaluate the identification and screening procedures for HFpEF outlined in this protocol. Additionally, the investigators aim to gauge the willingness of identified Danish adults with risk factors for HFpEF to participate in the study and to identify and address any barriers to their involvement. Overall, the investigators expect the results of this study can be used to guide future initiatives aimed at improving the identification and enrollment of patients with HFpEF, particularly among vulnerable populations.

Первичные конечные точки

• The primary objective of this study is to pilot the identification and screening procedures outlined in this protocol. [Срок оценки: From the invitation date until the end of the study (approximately 12 months).]

Вторичные конечные точки (1)

• Secondarily, we aim to assess the willingness of identified Danish adults with risk factors for HFpEF to participate in the study, as well as to identify and address any barriers to their involvement. [Срок оценки: From the end of the study until all analyses are completed (estimated to be from November 2025 to March 2026]

Критерии участия

Критерии включения

• Residence in the Capital Region of Denmark
• Age ≥ 50 years
• At least two risk factors for HFpEF defined as any of the following (for age ≥ 60 years, only one):

• Hypertension
• Diabetes mellitus
• Chronic kidney disease
• Atrial fibrillation
• BMI > 25 kg/m2
• Previous heart valve surgery
• Ischemic heart disease
• Obstructive sleep apnea
• Furosemide 40 mg

Критерии исключения

• Age ≥ 90 years
• Prevalent HF
• Dementia
• Nursing home
• Amyloidosis
• Hemodialysis
• Cancer diagnosed within the past 5 years (skin cancer not included)
• Prior solid organ transplantation
• Lung disease defined as any of the following:

• World Health Organization Group 1 pulmonary hypertension
• Chronic pulmonary embolism
• Lung fibrosis
• Chronic obstructive pulmonary disease (COPD)
• Home oxygen

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 1 центр

• Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiol — Hellerup

Идентификаторы

NCT: NCT06685237 · CPH-HFpEF · H-24022361

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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