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

Overview

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.

Interventions

• 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 durin

Primary outcome measures

• Exercise capacity [Time frame: From enrollment to the end of treatment at 12 weeks]
• Endothelial function [Time frame: From enrollment to the end of treatment at 12 weeks]
• Pulse wave velocity (PWV) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Radial augmentation index (rAIx) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Central augmentation index (cAIx) [Time frame: From enrollment to the end of treatment at 12 weeks]

Secondary outcome measures (12)

• Body weight [Time frame: From enrollment to the end of treatment at 12 weeks]
• Height [Time frame: From enrollment to the end of treatment at 12 weeks]
• Body mass index (BMI) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Waist circumference [Time frame: From enrollment to the end of treatment at 12 weeks]
• Body fat percentage [Time frame: From enrollment to the end of treatment at 12 weeks]
• Systolic blood pressure (SBP) [Time frame: From enrollment to the end of treatment at 12 week]
• Diastolic blood pressure (DBP) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Grip strength [Time frame: From enrollment to the end of treatment at 12 weeks]
• Step rate (cadence) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Heart rate [Time frame: From enrollment to the end of treatment at 12 weeks]
• Sleep duration [Time frame: From enrollment to the end of treatment at 12 weeks]
• Sleep quality score [Time frame: From enrollment to the end of treatment at 12 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07024810 · REG: 2025/PI0625

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗