HF - Heart FailurePIRIC-FEp StudNCT07024810
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
A study testing remote ischemic preconditioning in people with HF - Heart Failure, run by University of Castilla-La Mancha.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HF - Heart Failure
- What is being tested?
- remote ischemic preconditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Written informed consent
- Clinically stable for 6 weeks
- Optimal medical treatment for ≥6 weeks.
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- HF - Heart Failure
- Being tested
- remote ischemic preconditioning
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioningOther
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 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.
| Study group | Role | What they receive |
|---|---|---|
| remote ischemic preconditioning | Experimental | 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. Receives: Other: remote ischemic preconditioning |
| normal routine and to refrain from any new physical activity or change in eating habits. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
Central augmentation index (cAIx)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (30)
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
Body fat percentage
Body fat percentage will be assessed using an 8-electrode bioelectrical impedance analyzer (Tanita® BC-418 MA). The mean of two measurements will be recorded.
Unit of Measure: Percentage (%) Interpretation: Lower values may indicate improved body composition.
Measured: From enrollment to the end of treatment at 12 weeks
Systolic blood pressure (SBP)
Systolic blood pressure will be measured as the mean of two readings separated by 5 minutes. Measurements will be taken in a seated position using the Omron® H907 monitor.
Unit of Measure: Millimeters of mercury (mmHg) Interpretation: Lower SBP indicates improved cardiovascular function.
Measured: From enrollment to the end of treatment at 12 week
Diastolic blood pressure (DBP)
Diastolic blood pressure will be measured as the mean of two readings separated by 5 minutes, using the same protocol and device as for SBP.
Unit of Measure: Millimeters of mercury (mmHg) Interpretation: Lower DBP indicates improved cardiovascular function.
Measured: From enrollment to the end of treatment at 12 weeks
Grip strength
Muscular strength will be assessed using the TKK 5401 Grip-D dynamometer (Takey®, Tokyo, Japan). Manual grip force will be recorded in kilograms.
Unit of Measure: Kilograms (kg) Interpretation: Higher grip strength reflects better muscular function.
Measured: From enrollment to the end of treatment at 12 weeks
Step rate (cadence)
The average number of steps per minute will be monitored using the Fitbit Inspire 3 over a continuous 9-day period.
Unit of Measure: Steps per minute Interpretation: Higher cadence indicates greater physical activity.
Measured: From enrollment to the end of treatment at 12 weeks
Heart rate
Mean heart rate will be continuously recorded in 1-minute intervals using the Fitbit Inspire 3 for 9 consecutive days.
Unit of Measure: Beats per minute (bpm) Interpretation: Lower resting heart rate may indicate improved cardiovascular fitness.
Measured: From enrollment to the end of treatment at 12 weeks
Sleep duration
Daily sleep duration (in hours) will be recorded using the Fitbit Inspire 3 over a 9-day period.
Unit of Measure: Hours per night Interpretation: Longer sleep duration (within healthy ranges) is generally favorable.
Measured: From enrollment to the end of treatment at 12 weeks
Sleep quality score
Sleep quality will be estimated using proprietary algorithms from the Fitbit Inspire 3, generating a composite sleep score based on movement, interruptions, and time spent in sleep stages.
Unit of Measure: Units on a 0-100 scale Interpretation: Higher scores represent better sleep quality.
Measured: From enrollment to the end of treatment at 12 weeks
Metabolic equivalents (METs)
METs will be estimated based on movement and heart rate using the Fitbit Inspire 3, representing energy expenditure relative to rest.
Unit of Measure: METs Interpretation: Higher METs indicate more intense or sustained physical activity.
Measured: From enrollment to the end of treatment at 12 weeks
DNA sample collection for genotyping
Saliva samples (1-3 mL) will be collected in sterile tubes with a preservation reagent to maintain DNA integrity. Samples will be used for genotyping analysis.
Unit of Measure: Presence or absence of adequate sample for genotyping (Yes/No) Interpretation: Successful collection enables subsequent genetic analysis; no scoring or numerical outcome applies.
Measured: Baseline mesaurements
Physical activity level (IPAQ total MET-min/week)
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). It categorizes activity levels as low, moderate, or high, and estimates total weekly energy expenditure in MET-minutes.
Unit of Measure: MET-minutes per week Interpretation: Higher values indicate greater total physical activity.
Measured: From enrollment to the end of treatment at 12 weeks
Physical fitness self-perception (IFIS total score)
Physical fitness will be assessed using the International Fitness Scale (IFIS), a validated self-report questionnaire evaluating five components: general fitness, cardiorespiratory fitness, muscular strength, speed-agility, and flexibility. Each item is scored on a 5-point Likert scale (1 = very poor, 5 = very good).
Unit of Measure: Score (1-5 for each item, or total score range: 5-25) Interpretation: Higher scores indicate better perceived physical fitness.
Measured: From enrollment to the end of treatment at 12 weeks
Adherence to the Mediterranean diet (MEDAS-14 total score)
Adherence to the Mediterranean diet will be assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS-14). Each item is scored as 0 or 1, resulting in a total score ranging from 0 to 14.
Unit of Measure: Score (0-14) Interpretation: Higher scores indicate greater adherence to the Mediterranean dietary pattern.
Measured: From enrollment to the end of treatment at 12 weeks
Health-related quality of life (SF-12 total score)
The 12-item Short Form Health Survey (SF-12) will be used to assess general quality of life. It includes two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each score ranges from 0 to 100, with higher scores indicating better health status.
Unit of Measure: Score (0-100 for each component) Interpretation: Higher scores represent better perceived physical and mental health.
Measured: From enrollment to the end of treatment at 12 weeks
Heart failure-related quality of life (MLWHFQ total score)
The Minnesota Living With Heart Failure Questionnaire (MLWHFQ) evaluates the impact of heart failure on patients' quality of life. It contains 21 items rated from 0 (no impact) to 5 (very much), resulting in a total score ranging from 0 to 105.
Unit of Measure: Score (0-105) Interpretation: Lower scores indicate better quality of life and fewer symptoms related to heart failure.
Measured: From enrollment to the end of treatment at 12 weeks
Consumption of highly processed foods (SQ-HPF total score)
The frequency and quantity of consumption of highly processed foods will be assessed using the Short Questionnaire for the Assessment of Highly Processed Food Consumption (SQ-HPF). The questionnaire includes 14 food categories, each scored based on consumption frequency. The total score ranges from 0 to 28.
Unit of Measure: Score (0-28) Interpretation: Higher scores indicate more frequent consumption of highly processed foods.
Measured: From enrollment to the end of treatment at 12 weeks
Fasting glucose
Fasting plasma glucose will be measured using the Roche Diagnostics® Cobas 8000 system.
Unit of Measure: Milligrams per deciliter (mg/dL) Interpretation: Lower levels indicate better glycemic control.
Measured: From enrollment to the end of treatment at 12 weeks
Total cholesterol
Serum total cholesterol will be analyzed on the Roche Diagnostics® Cobas 8000 platform.
Unit of Measure: Milligrams per deciliter (mg/dL) Interpretation: Lower levels generally reflect better lipid profile.
Measured: From enrollment to the end of treatment at 12 weeks
Triglycerides
Serum triglycerides will be measured using the Roche Diagnostics® Cobas 8000 system.
Unit of Measure: Milligrams per deciliter (mg/dL) Interpretation: Lower values are associated with improved metabolic health.
Measured: From enrollment to the end of treatment at 12 weeks
HDL cholesterol
High-density lipoprotein cholesterol will be assessed via the Cobas 8000 system.
Unit of Measure: Milligrams per deciliter (mg/dL) Interpretation: Higher values are considered cardioprotective.
Measured: From enrollment to the end of treatment at 12 weeks
LDL cholesterol
Low-density lipoprotein cholesterol will be measured using the Roche Cobas 8000 analyzer.
Unit of Measure: Milligrams per deciliter (mg/dL) Interpretation: Lower values reduce cardiovascular risk.
Measured: From enrollment to the end of treatment at 12 weeks
Apolipoprotein A1
Apolipoprotein A1 will be determined with the Roche Diagnostics® Cobas 8000 system.
Unit of Measure: Milligrams per deciliter (mg/dL) Interpretation: Higher levels are associated with better HDL function.
Measured: From enrollment to the end of treatment at 12 weeks
Apolipoprotein B
Apolipoprotein B levels will be measured using the Cobas 8000 platform. Unit of Measure: Milligrams per deciliter (mg/dL) Interpretation: Lower values are associated with reduced atherogenic risk.
Measured: From enrollment to the end of treatment at 12 weeks
Fasting insulin
Insulin concentration will be measured using the Abbott® Architect platform. Unit of Measure: Micro-international units per milliliter (µIU/mL) Interpretation: Lower fasting insulin suggests better insulin sensitivity.
Measured: From enrollment to the end of treatment at 12 weeks
High-sensitivity C-reactive protein (hs-CRP)
Serum hs-CRP will be assessed using the Roche Cobas 8000 system. Unit of Measure: Milligrams per liter (mg/L) Interpretation: Lower levels reflect lower systemic inflammation.
Measured: From enrollment to the end of treatment at 12 weeks
Glycated hemoglobin (HbA1c)
HbA1c will be determined using high-performance liquid chromatography (HPLC) on the ADAMS A1c HA-8180V analyzer (A. Menarini Diagnostics®), NGSP-certified method.
Unit of Measure: Percentage (%) Interpretation: Lower values indicate improved long-term glycemic control.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Oct 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HF - Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024810
- Sponsor's protocol ID
- REG: 2025/PI0625
- Acronym
- PIRIC-FEp Stud
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07024810
- Acronym / sponsor ID
- PIRIC-FEp Stud / REG: 2025/PI0625
- Conditions
- HF - Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote ischemic preconditioning | Experimental | Other: remote ischemic preconditioningParticipants 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. |
| normal routine and to refrain from any new physical activity or change in eating habits. | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HF-PEF (diagnosis according to the ESC 2021 criteria)
- Sedentary men and women (structured exercise <2 x 30 min/week).
- Age ≥40 years
- Written informed consent
- Clinically stable for 6 weeks
Key exclusion criteria (11 listed)
- Non-cardiac causes of HF symptoms:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic preconditioningParticipants 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. | Other | remote ischemic preconditioning |
Primary outcome
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.
30 secondary outcomes
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
Metabolic equivalents (METs)
Time frame: From enrollment to the end of treatment at 12 weeks
DNA sample collection for genotyping
Time frame: Baseline mesaurements
Physical activity level (IPAQ total MET-min/week)
Time frame: From enrollment to the end of treatment at 12 weeks
Physical fitness self-perception (IFIS total score)
Time frame: From enrollment to the end of treatment at 12 weeks
Adherence to the Mediterranean diet (MEDAS-14 total score)
Time frame: From enrollment to the end of treatment at 12 weeks
Health-related quality of life (SF-12 total score)
Time frame: From enrollment to the end of treatment at 12 weeks
Heart failure-related quality of life (MLWHFQ total score)
Time frame: From enrollment to the end of treatment at 12 weeks
Consumption of highly processed foods (SQ-HPF total score)
Time frame: From enrollment to the end of treatment at 12 weeks
Fasting glucose
Time frame: From enrollment to the end of treatment at 12 weeks
Total cholesterol
Time frame: From enrollment to the end of treatment at 12 weeks
Triglycerides
Time frame: From enrollment to the end of treatment at 12 weeks
HDL cholesterol
Time frame: From enrollment to the end of treatment at 12 weeks
LDL cholesterol
Time frame: From enrollment to the end of treatment at 12 weeks
Apolipoprotein A1
Time frame: From enrollment to the end of treatment at 12 weeks
Apolipoprotein B
Time frame: From enrollment to the end of treatment at 12 weeks
Fasting insulin
Time frame: From enrollment to the end of treatment at 12 weeks
High-sensitivity C-reactive protein (hs-CRP)
Time frame: From enrollment to the end of treatment at 12 weeks
Glycated hemoglobin (HbA1c)
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic preconditioning in people with HF - Heart Failure, run by University of Castilla-La Mancha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Otero-Luis (+34649277738, iotero98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.