NCT07024810

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HF - Heart Failure

Interventions

Type	Name	Description
OTHER	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 during their first PIR session and every 15 days to ensure that it is performed correctly and, they will be free to perform the PIR at any time during the day and will record it in a diary to monitor compliance. Participants will be instructed to follow their normal routine and refrain from engaging in any new physical activity or changing their eating habits.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-02-28
• Completion: 2027-02-28
• First posted: 2025-06-17
• Last updated: 2025-06-17