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.
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
Significant valvular or coronary artery disease
Uncontrolled hypertension or arrhythmias
Primary cardiomyopathies
Significant pulmonary disease (FEV1<50% predicted, GOLD III-IV)
Parallel
remote ischemic preconditioning
Other interventionParticipants 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.
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.
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.
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.
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.
Body weight
Weight will be assessed using a Seca® 861 digital scale. The mean of two measurements will be recorded, with participants barefoot and wearing light clothing. Unit of Measure: Kilograms (kg) Interpretation: Lower weight may indicate a reduction in overall adiposity depending on context.
Height
Height will be measured using a wall-mounted stadiometer (Seca® 222). The mean of two measurements will be recorded with participants barefoot, in upright position. Unit of Measure: Meters (m) Interpretation: Stable in adults; used to calculate BMI.
Body mass index (BMI)
BMI will be calculated as weight in kilograms divided by the square of height in meters (kg/m²). Unit of Measure: kg/m² Interpretation: Lower values generally indicate lower body fat in the absence of muscle mass loss.
Waist circumference
Waist circumference will be measured with a flexible tape at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, at the end of a normal exhalation. The average of three measurements will be used. Unit of Measure: Centimeters (cm) Interpretation: Lower values suggest reduced central adiposity.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
