Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction

Официальное название

The First Affiliated Hospital of Xinjiang Medical University

Обзор

This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Подробное описание

Heart failure is one of the most important diseases worldwide, with a 5-year mortality of up to 75% in symptomatic patients. While substantial progress has been made in the treatment of patients with reduced left ventricular ejection fraction (HFrEF), mortality for patients with heart failure and preserved ejection fraction (HFpEF) remains unchanged, despite a comparable prevalence and mortality of the disease as for heart failure with reduced ejection fraction. Heart failure with preserved ejection fraction has a high mortality, which is contrasted by a total absence of therapy options besides symptomatic diuretic treatment. This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Вмешательства

• Процедура Sham procedure and maintenance of heart failure medications
  Sham intervention, maintenance of heart failure medications
• Процедура Renal denervation and maintenance of heart failure medications
  Renal denervation and maintenance of heart failure medications

Первичные конечные точки

• Change from baseline E/E' at 12 months [Срок оценки: 12 months after treatment]

Вторичные конечные точки (1)

• Number of participants with adverse events [Срок оценки: 1 year]

Критерии участия

Критерии включения

• signs or symptoms of heart failure;
• normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
• evidence of diastolic LV dysfunction.
• Individual should fulfill the diagnostic WHO criteria for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (< 140/90mmHg by 24 hour ambulatory BP measurement).
• Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.

Критерии исключения

• Known secondary cause of hypertension
• Anatomy not eligible for renal denervation
• Systolic heart failure (LVEF < 50%)
• Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.
• Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation).
• Individual is pregnant, nursing or planning to be pregnant.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi

Идентификаторы

NCT: NCT05715697 · 20230126-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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