Acute Effect of Nurse-assessed Remote Ischemic Preconditioning on Improving Vascular Parameters in Patients With Suspected Heart Failure With Preserved Ejection Fraction

Обзор

The PIRIC-FEp study will be a randomized clinical trial in sedentary patients with suspected heart failure with preserved ejection fraction. Objectives: 1) To evaluate the acute efficacy of remote ischemic preconditioning performed by nurses, a noninvasive cardioprotective intervention that uses cycles of ischemia and reperfusion in the extremities, in improving vascular parameters. 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. The control group will receive no intervention. All participants will be examined, at baseline, 0 minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention. Different vascular parameters will be evaluated, including peripheral and central Systolic and Blood Pressure, peripheral and central Mean Arterial Pressure, peripheral and central Pulse Pressure, Heart Rate, Cardiac Output, Stroke Volume, Peripheral Vascular Resistance, aortic Pulse Wave Velocity and Augmentation Index normalized to a heart rate of 75 beats per minute. 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

• Процедура remote ischemic preconditioning
  Participants randomized to the remote ischemic preconditioning intervention group will receive a hand-held blood pressure device (Welch Allyn DuraShock™ DS45, NY, USA) to self-administer remote ischemic preconditioning. 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. The arm on which participants will apply the PIR is the left arm. Participants will be supervised during t

Первичные конечные точки

• Systolic Blood Pressure [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Diastolic Blood Pressure [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Diastolic Blood Pressure [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Pulse Pressure [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Heart Rate [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Central Systolic Blood Pressure [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Central Diastolic Blood Pressure [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Central Pulse Pressure [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Cardiac Output [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]
• Stroke Volume [Срок оценки: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention]

Критерии участия

Критерии включения

• Signs and symptoms of Heart Failure (Clinical suspicion of Heart Failure)
• 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 Heart Failure 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.
• 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

Испания · 1 центр

• Iván — Cuenca

Идентификаторы

NCT: NCT07365501 · ND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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