Effect of Nurse-assessed Remote Ischemic Preconditioning on Improving Exercise Capacity, Endothelial Function, and Arterial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction

Обзор

The PIRIC-FEp study will be a randomized clinical trial in sedentary patients with heart failure and stable preserved ejection fraction. Objectives: 1) To evaluate the efficacy of remote ischemic preconditioning performed by nurses, a noninvasive cardioprotective intervention that uses cycles of ischemia and reperfusion in the extremities, in improving exercise capacity, cardiac function, endothelial function and arterial stiffness, and 2) To analyze its impact on quality of life and its cost-effectiveness compared to conventional treatment. Methodology: Patients will be recruited in Health Centers in the city. Those assigned to the intervention group will wear a self-administered blood pressure cuff, inflated to 220 mmHg for 5 minutes, followed by 5 minutes of deflation, in repeated cycles four times, five days a week for three months. The control group will receive standard counseling. All participants will be examined, at baseline and at three months. Adherence will be defined as completing at least 70% of the sessions. Different parameters will be evaluated, including sociodemographic variables, patient's medical history, echocardiography, cardiopulmonary exercise test, endothelial function, arterial stiffness, quality of life, spirometry, blood tests, among others. The study will be approved by an Ethics Committee, participants will be informed and will have to sign a written consent. The statistical analysis will include three phases: verification of randomization, use of covariance models for dependent variables, and sensitivity analysis with propensity score matching. All analyses will be performed on an intention-to-treat basis.

Вмешательства

• Другое remote ischemic preconditioning
  Participants randomized to the PIR intervention group will receive a hand-held blood pressure device (Welch Allyn DuraShock™ DS45, NY, USA) to self-administer PIR. The cuff will be placed around the upper arm and inflated to 220 mmHg for 5 minutes, followed by 5 minutes of deflation, and this cycle will be repeated another three times. This process will be performed 5 days a week for 3 months. The arm on which participants will apply the PIR is the left arm. Participants will be supervised durin

Первичные конечные точки

• Exercise capacity [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Endothelial function [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Pulse wave velocity (PWV) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Radial augmentation index (rAIx) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Central augmentation index (cAIx) [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (12)

• Body weight [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Height [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Body mass index (BMI) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Waist circumference [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Body fat percentage [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Systolic blood pressure (SBP) [Срок оценки: From enrollment to the end of treatment at 12 week]
• Diastolic blood pressure (DBP) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Grip strength [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Step rate (cadence) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Heart rate [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Sleep duration [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Sleep quality score [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• HF-PEF (diagnosis according to the ESC 2021 criteria)

• Signs and symptoms of HF
• A left ventricular ejection fraction ≥50%.
• Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of left ventricular diastolic dysfunction/elevated left ventricular filling pressures, including elevated natriuretic peptides
• Sedentary men and women (structured exercise <2 x 30 min/week).
• Age ≥40 years
• Written informed consent
• Clinically stable for 6 weeks
• Optimal medical treatment for ≥6 weeks.

Критерии исключения

• Non-cardiac causes of HF symptoms:

• Significant valvular or coronary artery disease
• Uncontrolled hypertension or arrhythmias
• Primary cardiomyopathies
• Significant pulmonary disease (FEV1<50% predicted, GOLD III-IV)
• Inability to exercise or conditions that may interfere with exercise intervention.
• Myocardial infarction within the last 3 months.
• Patients with diabetes and/or peripheral vascular disease.
• Signs of ischemia during maximal cardiopulmonary stress test.
• Comorbidity that may influence prognosis at one year.
• Participation in another clinical trial

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07024810 · REG: 2025/PI0625

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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