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 (PIRIC-FEp Stud)

University of Castilla-La Mancha

Status: Not yet enrolling

Conditions: HF - Heart Failure

Treatments: Other: remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT07024810

REG: 2025/PI0625

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HF-PEF (diagnosis according to the ESC 2021 criteria)

   1. Signs and symptoms of HF
   2. A left ventricular ejection fraction ≥50%.
   3. 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

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 HF 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. Signs of ischemia during maximal cardiopulmonary stress test.

7. Comorbidity that may influence prognosis at one year.

8. Participation in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

remote ischemic preconditioning

Experimental group

Description:

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.

Treatment:

Other: remote ischemic preconditioning

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

No Intervention group