Clinical trial NCT07024810: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HF - Heart Failure
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exercise capacity
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Endothelial function
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Pulse wave velocity (PWV)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Radial augmentation index (rAIx)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Central augmentation index (cAIx)
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Body weight
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Height
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Body mass index (BMI)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Waist circumference
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Body fat percentage
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Systolic blood pressure (SBP)
timeFrame: From enrollment to the end of treatment at 12 week
measure: Diastolic blood pressure (DBP)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Grip strength
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Step rate (cadence)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Heart rate
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Sleep duration
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Sleep quality score
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Metabolic equivalents (METs)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: DNA sample collection for genotyping
timeFrame: Baseline mesaurements
measure: Physical activity level (IPAQ total MET-min/week)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Physical fitness self-perception (IFIS total score)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Adherence to the Mediterranean diet (MEDAS-14 total score)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Health-related quality of life (SF-12 total score)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Heart failure-related quality of life (MLWHFQ total score)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Consumption of highly processed foods (SQ-HPF total score)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Fasting glucose
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Total cholesterol
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Triglycerides
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: HDL cholesterol
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: LDL cholesterol
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Apolipoprotein A1
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Apolipoprotein B
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Fasting insulin
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: High-sensitivity C-reactive protein (hs-CRP)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Glycated hemoglobin (HbA1c)
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
Study officials:
References: