Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF

Официальное название

Prevalence and Prediction of Transthyretin Amyloidosis in Ambulatory Patients With Heart Failure With Preserved Ejection Fraction

Обзор

Recent studies have shown that transthyretin amyloidosis (ATTR) can sometimes cause a type of heart failure where the pumping function of the heart is normal, also known as Heart Failure with Preserved Ejection Fraction (HFpEF) or diastolic heart failure. In this single center diagnostic study, we will evaluate for ATTR in patients with HFpEF in order to to determine how frequently this occurs and how we can predict which heart failure patients may have TTR amyloidosis. Our goal is to identify amyloidosis in heart failure patients earlier so that they can start treatment.

Подробное описание

Patients 65-years and older with HFpEF will be enrolled to participate in this single center, event driven (positive nuclear amyloid scan also known as 99mTc-pyrophosphate SPECT scan) study.

During the single study visit the following will be obtained:

* 99mTc-pyrophosphate SPECT scan * Blood and DNA (optional) sample collection * Questionnaires in regards to neuropathy, carpal tunnel, frailty, and Heart failure symptoms and how they may affect ones quality of life * 6-Minute Walk Test * ECG (electrocardiogram) * Echocardiogram

Electronic health records will be reviewed for up to 5 years in order to determine hospitalization and survival of the study participants. Clinical outcomes of interest include a combined endpoint of days alive outside of the hospital from heart failure hospitalizations at one and five years, presence of autonomic neuropathy, presence of carpal tunnel syndrome, presence of polyneuropathy. Additionally, Individual clinical endpoints are also endpoints of interest.

The results from this study will be used to determine how frequently heart failure patients have transthyretin amyloidosis in their heart and better understand their symptoms. We hope that better understanding transthyretin amyloidosis in heart failure patients will help us identify affected patients so that they can receive treatment.

Вмешательства

• Диагностический тест 99mTc-pyrophosphate Scintigraphy
  Cardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer

Первичные конечные точки

• Diagnosis of 99mTc-pyrophosphate scan positive ATTR [Срок оценки: Day 1 (day of study visit)]

Вторичные конечные точки (3)

• New York Heart Association function classification [Срок оценки: Day 1 (day of study visit)]
• Impact of HF as assessed by Kansas City Cardiomyopathy Questionnaire [Срок оценки: Day 1 (day of study visit)]
• Exercise capacity as determined by a 6-minute walk test [Срок оценки: Day 1 (day of study visit)]

Критерии участия

Критерии включения

• Patients with a confirmed diagnosis of HFpEF.
• Age ≥65 years old

Критерии исключения

• End stage chronic kidney disease on dialysis (CKD stage 5 as defined as eGFR <15mL/min)
• no history of HFrEF (LVEF<40%) with the exception of low LVEF in the setting of acute decompensation, AF RVR, ACS/MI, etc
• Negative 99mTc-pyrophosphate scan within a year
• Unable to lie down for 15 minutes for the 99mTc-pyrophosphate scan
• Known diagnosis of amyloidosis
• Severe valvular heart disease that is uncorrected (moderate to severe is considered exclusionary)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT05577819 · 2020P002061

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗