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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 48
- Primary Endpoint
- Exercise capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
normal routine and to refrain from any new physical activity or change in eating habits.
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.
Intervention: remote ischemic preconditioning (Other)
Outcomes
Primary Outcomes
Exercise capacity
Time Frame: From enrollment to the end of treatment at 12 weeks
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
Time Frame: From enrollment to the end of treatment at 12 weeks
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)
Time Frame: From enrollment to the end of treatment at 12 weeks
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)
Time Frame: From enrollment to the end of treatment at 12 weeks
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.
Central augmentation index (cAIx)
Time Frame: From enrollment to the end of treatment at 12 weeks
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.
Secondary Outcomes
- 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)
- Systolic blood pressure (SBP)(From enrollment to the end of treatment at 12 week)
- Diastolic blood pressure (DBP)(From enrollment to the end of treatment at 12 weeks)
- Grip strength(From enrollment to the end of treatment at 12 weeks)
- Step rate (cadence)(From enrollment to the end of treatment at 12 weeks)
- Heart rate(From enrollment to the end of treatment at 12 weeks)
- Sleep duration(From enrollment to the end of treatment at 12 weeks)
- Sleep quality score(From enrollment to the end of treatment at 12 weeks)
- Metabolic equivalents (METs)(From enrollment to the end of treatment at 12 weeks)
- DNA sample collection for genotyping(Baseline mesaurements)
- Physical activity level (IPAQ total MET-min/week)(From enrollment to the end of treatment at 12 weeks)
- Physical fitness self-perception (IFIS total score)(From enrollment to the end of treatment at 12 weeks)
- Adherence to the Mediterranean diet (MEDAS-14 total score)(From enrollment to the end of treatment at 12 weeks)
- Health-related quality of life (SF-12 total score)(From enrollment to the end of treatment at 12 weeks)
- Heart failure-related quality of life (MLWHFQ total score)(From enrollment to the end of treatment at 12 weeks)
- Consumption of highly processed foods (SQ-HPF total score)(From enrollment to the end of treatment at 12 weeks)
- Fasting glucose(From enrollment to the end of treatment at 12 weeks)
- Total cholesterol(From enrollment to the end of treatment at 12 weeks)
- Triglycerides(From enrollment to the end of treatment at 12 weeks)
- HDL cholesterol(From enrollment to the end of treatment at 12 weeks)
- LDL cholesterol(From enrollment to the end of treatment at 12 weeks)
- Apolipoprotein A1(From enrollment to the end of treatment at 12 weeks)
- Apolipoprotein B(From enrollment to the end of treatment at 12 weeks)
- Fasting insulin(From enrollment to the end of treatment at 12 weeks)
- High-sensitivity C-reactive protein (hs-CRP)(From enrollment to the end of treatment at 12 weeks)
- Glycated hemoglobin (HbA1c)(From enrollment to the end of treatment at 12 weeks)