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

NCT07024810 | Not Yet Recruiting DMC

• 1 other identifier: REG: 2025/PI0625
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• Exercise capacity

  The 6-minute walking test will be performed in a 30-meter corridor, which will be carried out by walking back and forth along this section, which will be delimited by cone-type indicators. These signs shall be placed at a distance of 29 meters from each other, leaving 0.5 meters at each end for the subject to turn. The test shall be performed accompanied by the examiner. Unit of measure: Meters. Interpretation: Higher values indicate better exercise capacity.

  From enrollment to the end of treatment at 12 weeks

• Endothelial function

  Carotid intima-media layer thickness: by ultrasound with the Sonosite SII device (Sonosite Inc., Bothell, Washington, USA). Unit of Measure: Millimeters (mm) Interpretation: Lower values indicate better endothelial function.

  From enrollment to the end of treatment at 12 weeks

• Pulse wave velocity (PWV)

  Arterial stiffness will be assessed using the SphygmoCor System to calculate carotid-femoral pulse wave velocity. Unit of Measure: Meters per second (m/s) Interpretation: Lower values indicate better arterial elasticity.

  From enrollment to the end of treatment at 12 weeks

• Radial augmentation index (rAIx)

  The radial augmentation index will be calculated using the SphygmoCor System. Formula: (SBP2 - DBP)/(SBP - DBP) x 100 (%). Unit of Measure: Percentage (%) Interpretation: Lower values indicate better vascular function.

  From enrollment to the end of treatment at 12 weeks

• Central augmentation index (cAIx)

  The central augmentation index will be calculated using the SphygmoCor System. Formula: Central pulse pressure increase x 100 / Pulse pressure. Unit of Measure: Percentage (%) Interpretation: Lower values indicate better vascular function.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (30)

• Body weight

  From enrollment to the end of treatment at 12 weeks

• Height

  From enrollment to the end of treatment at 12 weeks

• Body mass index (BMI)

  From enrollment to the end of treatment at 12 weeks

• Waist circumference

  From enrollment to the end of treatment at 12 weeks

• Body fat percentage

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

remote ischemic preconditioning

EXPERIMENTAL

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.

Other: remote ischemic preconditioning

normal routine and to refrain from any new physical activity or change in eating habits.

NO INTERVENTION

Interventions

remote ischemic preconditioning OTHER

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.

remote ischemic preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Iris Otero-Luis

CONTACT

+34649277738; iotero98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 17, 2025
• Study Start: October 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share