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

NCT07365501 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-06

No results posted yet for this study

Summary

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.

Conditions

  • HF - Heart Failure

Interventions

PROCEDURE

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 the PIR session by a nurse to ensure that it is performed correctly.

Sponsors & Collaborators

  • Universidad Pontificia Comillas

    collaborator OTHER

  • University of Castilla-La Mancha

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07365501 on ClinicalTrials.gov