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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HF - Heart Failure
• Intervention / Treatment: Procedure: remote ischemic preconditioning

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cuenca
    • Cuenca, Cuenca, Spain, 16001
      • Iván

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signs and symptoms of Heart Failure (Clinical suspicion of Heart Failure)
2. Sedentary men and women (structured exercise <2 x 30 min/week).
3. Age ≥40 years
4. Written informed consent
5. Clinically stable for 6 weeks
6. Optimal medical treatment for ≥6 weeks.

Exclusion Criteria:

1. Non-cardiac causes of Heart Failure symptoms:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No remote ischemic preconditioning; No intervention
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	he maximum arterial pressure during ventricular systole, measured at the brachial artery by the Mobil-O-Graph using oscillometric technology.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Diastolic Blood Pressure	The minimum arterial pressure during ventricular diastole, measured at the brachial artery by the Mobil-O-Graph using oscillometric technology.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Diastolic Blood Pressure	The average arterial pressure over the cardiac cycle, calculated by the Mobil-O-Graph from oscillometric pressure signals and systolic and diastolic blood pressure values.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Pulse Pressure	The difference between systolic and diastolic brachial blood pressure, calculated by the Mobil-O-Graph and reflecting the pulsatile component of arterial load.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Heart Rate	The number of heart beats per minute, determined by the Mobil-O-Graph from the time interval between consecutive oscillometric pulse waves.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Central Systolic Blood Pressure	The estimated systolic pressure in the ascending aorta, derived by the Mobil-O-Graph through reconstruction of the central pulse wave from the brachial oscillometric signal.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Central Diastolic Blood Pressure	The estimated diastolic pressure at the central (aortic) level, calculated by the Mobil-O-Graph using pulse wave analysis algorithms.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Central Pulse Pressure	The difference between estimated central systolic and diastolic blood pressure, calculated by the Mobil-O-Graph to represent aortic pulsatile pressure.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Cardiac Output	The volume of blood pumped by the heart per minute, estimated by the Mobil-O-Graph from stroke volume calculations combined with heart rate.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Stroke Volume	The volume of blood ejected by the left ventricle per heartbeat, estimated by the Mobil-O-Graph using hemodynamic modeling based on pulse wave analysis.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Peripheral Vascular Resistance	he resistance of the peripheral circulation to blood flow, estimated by the Mobil-O-Graph from calculated mean arterial pressure and cardiac output.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Pulse Wave Velocity	The speed at which the arterial pulse wave propagates through the arterial tree, estimated by the Mobil-O-Graph as an indirect marker of arterial stiffness.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Augmentation Index normalized to 75 bpm	An index quantifying the contribution of reflected pressure waves to central arterial pressure, estimated by the Mobil-O-Graph from the reconstructed central pulse wave and normalized to a heart rate of 75 beats per minute.	Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Universidad Pontificia Comillas

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: ND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No