Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction

Официальное название

A Dynamic, Multiple-biomarker Approach Aiming for Individualized Treatment of Heart Failure with Preserved Ejection Fraction (ADAPT-HFpEF)

Обзор

The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF. Moreover several secondary objectives will be investigated.

Подробное описание

This is a prospective, observational multi-center cohort study which will be conducted at the cardiology departments of the Erasmus Medical Centre (EMC) as well as five other hospitals. A total of 200 HFpEF patients will be included in the study via the outpatient clinics. The follow-up period will constitute a minimum of 2 years and a maximum of 3.5 years. Clinical data will be collected at baseline and blood samples will be collected at baseline and subsequently every 6 months.

Первичные конечные точки

• The primary endpoint is the number of participants with a combined endpoint of: urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and cardiovascular death. [Срок оценки: Every 6 months, up to 3,5 years]

Вторичные конечные точки (7)

• Number of participants with urgent visit resulting in intravenous therapy for heart failure [Срок оценки: Every 6 months, up to 3,5 years]
• Number of patients with hospital readmission for acute or worsened HF [Срок оценки: Every 6 months, up to 3.5 years]
• Number of participants with cardiovascular death. [Срок оценки: Every 6 months, up to 3.5 years]
• Number of participants with the combined endpoint urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and all-cause death. [Срок оценки: Every 6 months, up to 3,5 years]
• Number of partcipants with all-cause death [Срок оценки: Every 6 months, up to 3,5 years]
• Number of participants with the combined endpoint of myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) [Срок оценки: Every 6 months, up to 3,5 years]
• Number of participants with cardiovascular disease (includes all of the above-mentioned components, except all-cause death) [Срок оценки: Every 6 months, up to 3,5 years]

Критерии участия

Критерии включения

• Age of 18 years or older
• Capable of understanding and signing informed consent
• A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or/and a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score of 6 or higher.

Критерии исключения

• History of LVEF ≤40%
• Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion
• Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at the time of screening
• Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
• COPD Gold stage IV
• Congenital heart disease
• Pregnancy
• Coexistent condition with life expectancy of <1 year
• Unlikely to appear at all scheduled follow-up visits
• Linguistic barrier

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 6 центров

• Noordwest Ziekenhuisgroep — Alkmaar
• Amsterdam UMC — Amsterdam
• OLVG Ziekenhuis — Amsterdam
• Franciscus Gasthuis & Vlietland Ziekenhuis — Rotterdam
• Erasmus MC — Rotterdam
• Ikazia Ziekenhuis — Rotterdam

Идентификаторы

NCT: NCT06785506 · MEC-2022-0408

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗