HF - Heart FailurePIRIC-FEpNCT07365501
Acute Effect of Nurse-assessed Remote Ischemic Preconditioning on Improving Vascular Parameters in Patients With Suspected 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 at 1 site in Spain.
Trial summary
The PIRIC-FEp study will be a randomized clinical trial in sedentary patients with suspected heart failure with preserved ejection fraction. Objectives: 1) To evaluate the acute 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- 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
- Signs and symptoms of Heart Failure (Clinical suspicion of Heart Failure)
- 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.
Who cannot join
- Non-cardiac causes of Heart Failure 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.
Show all 10Show fewer
- Myocardial infarction within the last 3 months.
- Patients with diabetes and/or peripheral vascular disease.
- Comorbidity that may influence prognosis at one year.
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country. 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 suspected heart failure with preserved ejection fraction.
Objectives: 1) To evaluate the acute efficacy of remote ischemic preconditioning performed by nurses, a noninvasive cardioprotective intervention that uses cycles of ischemia and reperfusion in the extremities, in improving vascular parameters.
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. The control group will receive no intervention. All participants will be examined, at baseline, 0 minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention. Different vascular parameters will be evaluated, including peripheral and central Systolic and Blood Pressure, peripheral and central Mean Arterial Pressure, peripheral and central Pulse Pressure, Heart Rate, Cardiac Output, Stroke Volume, Peripheral Vascular Resistance, aortic Pulse Wave Velocity and Augmentation Index normalized to a heart rate of 75 beats per minute. 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 preconditioningProcedure or surgery
Participants randomized to the remote ischemic preconditioning intervention group will receive a hand-held blood pressure device (Welch Allyn DuraShock™ DS45, NY, USA) to self-administer remote ischemic preconditioning. 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. The arm on which participants will apply the PIR is the left arm. Participants will be supervised during the PIR session by a nurse to ensure that it is performed correctly.
| Study group | Role | What they receive |
|---|---|---|
| remote ischemic preconditioning | Experimental | Participants randomized to the remote ischemic preconditioning intervention group will receive a hand-held blood pressure device (Welch Allyn DuraShock™ DS45, NY, USA) to self-administer remote ischemic preconditioning. 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. Receives: Procedure: remote ischemic preconditioning |
| No remote ischemic preconditioning | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
he maximum arterial pressure during ventricular systole, measured at the brachial artery by the Mobil-O-Graph using oscillometric technology.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Diastolic Blood Pressure
The minimum arterial pressure during ventricular diastole, measured at the brachial artery by the Mobil-O-Graph using oscillometric technology.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Diastolic Blood Pressure
The average arterial pressure over the cardiac cycle, calculated by the Mobil-O-Graph from oscillometric pressure signals and systolic and diastolic blood pressure values.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Pulse Pressure
The difference between systolic and diastolic brachial blood pressure, calculated by the Mobil-O-Graph and reflecting the pulsatile component of arterial load.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Heart Rate
The number of heart beats per minute, determined by the Mobil-O-Graph from the time interval between consecutive oscillometric pulse waves.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Central Systolic Blood Pressure
The estimated systolic pressure in the ascending aorta, derived by the Mobil-O-Graph through reconstruction of the central pulse wave from the brachial oscillometric signal.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Central Diastolic Blood Pressure
The estimated diastolic pressure at the central (aortic) level, calculated by the Mobil-O-Graph using pulse wave analysis algorithms.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Central Pulse Pressure
The difference between estimated central systolic and diastolic blood pressure, calculated by the Mobil-O-Graph to represent aortic pulsatile pressure.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Cardiac Output
The volume of blood pumped by the heart per minute, estimated by the Mobil-O-Graph from stroke volume calculations combined with heart rate.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Stroke Volume
The volume of blood ejected by the left ventricle per heartbeat, estimated by the Mobil-O-Graph using hemodynamic modeling based on pulse wave analysis.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Peripheral Vascular Resistance
he resistance of the peripheral circulation to blood flow, estimated by the Mobil-O-Graph from calculated mean arterial pressure and cardiac output.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Pulse Wave Velocity
The speed at which the arterial pulse wave propagates through the arterial tree, estimated by the Mobil-O-Graph as an indirect marker of arterial stiffness.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Augmentation Index normalized to 75 bpm
An index quantifying the contribution of reflected pressure waves to central arterial pressure, estimated by the Mobil-O-Graph from the reconstructed central pulse wave and normalized to a heart rate of 75 beats per minute.
Measured: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Oct 2025
- Primary completion28 Feb 2027 (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
- Collaborators
- Universidad Pontificia Comillas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365501
- Sponsor's protocol ID
- ND
- Acronym
- PIRIC-FEp
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2026
- Last updated
- 6 Mar 2026
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Nurse-assessed Remote Ischemic Preconditioning on Improving Vascular Parameters in Patients With Suspected Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07365501
- Acronym / sponsor ID
- PIRIC-FEp / ND
- Conditions
- HF - Heart Failure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Universidad Pontificia Comillas
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 Jan 2026 (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 suspected heart failure with preserved ejection fraction.
Objectives: 1) To evaluate the acute efficacy of remote ischemic preconditioning performed by nurses, a noninvasive cardioprotective intervention that uses cycles of ischemia and reperfusion in the extremities, in improving vascular parameters.
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. The control group will receive no intervention. All participants will be examined, at baseline, 0 minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention. Different vascular parameters will be evaluated, including peripheral and central Systolic and Blood Pressure, peripheral and central Mean Arterial Pressure, peripheral and central Pulse Pressure, Heart Rate, Cardiac Output, Stroke Volume, Peripheral Vascular Resistance, aortic Pulse Wave Velocity and Augmentation Index normalized to a heart rate of 75 beats per minute. 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 | Procedure: remote ischemic preconditioningParticipants randomized to the remote ischemic preconditioning intervention group will receive a hand-held blood pressure device (Welch Allyn DuraShock™ DS45, NY, USA) to self-administer remote ischemic preconditioning. 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. |
| No remote ischemic preconditioning | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signs and symptoms of Heart Failure (Clinical suspicion of Heart Failure)
- 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 (10 listed)
- Non-cardiac causes of Heart Failure 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 remote ischemic preconditioning intervention group will receive a hand-held blood pressure device (Welch Allyn DuraShock™ DS45, NY, USA) to self-administer remote ischemic preconditioning. 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. The arm on which participants will apply the PIR is the left arm. Participants will be supervised during the PIR session by a nurse to ensure that it is performed correctly. | Procedure or surgery | remote ischemic preconditioning |
Primary outcome
Systolic Blood Pressure
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
he maximum arterial pressure during ventricular systole, measured at the brachial artery by the Mobil-O-Graph using oscillometric technology.
Diastolic Blood Pressure
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The minimum arterial pressure during ventricular diastole, measured at the brachial artery by the Mobil-O-Graph using oscillometric technology.
Diastolic Blood Pressure
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The average arterial pressure over the cardiac cycle, calculated by the Mobil-O-Graph from oscillometric pressure signals and systolic and diastolic blood pressure values.
Pulse Pressure
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The difference between systolic and diastolic brachial blood pressure, calculated by the Mobil-O-Graph and reflecting the pulsatile component of arterial load.
Heart Rate
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The number of heart beats per minute, determined by the Mobil-O-Graph from the time interval between consecutive oscillometric pulse waves.
Central Systolic Blood Pressure
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The estimated systolic pressure in the ascending aorta, derived by the Mobil-O-Graph through reconstruction of the central pulse wave from the brachial oscillometric signal.
Central Diastolic Blood Pressure
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The estimated diastolic pressure at the central (aortic) level, calculated by the Mobil-O-Graph using pulse wave analysis algorithms.
Central Pulse Pressure
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The difference between estimated central systolic and diastolic blood pressure, calculated by the Mobil-O-Graph to represent aortic pulsatile pressure.
Cardiac Output
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The volume of blood pumped by the heart per minute, estimated by the Mobil-O-Graph from stroke volume calculations combined with heart rate.
Stroke Volume
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The volume of blood ejected by the left ventricle per heartbeat, estimated by the Mobil-O-Graph using hemodynamic modeling based on pulse wave analysis.
Peripheral Vascular Resistance
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
he resistance of the peripheral circulation to blood flow, estimated by the Mobil-O-Graph from calculated mean arterial pressure and cardiac output.
Pulse Wave Velocity
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
The speed at which the arterial pulse wave propagates through the arterial tree, estimated by the Mobil-O-Graph as an indirect marker of arterial stiffness.
Augmentation Index normalized to 75 bpm
Time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention
An index quantifying the contribution of reflected pressure waves to central arterial pressure, estimated by the Mobil-O-Graph from the reconstructed central pulse wave and normalized to a heart rate of 75 beats per minute.
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 6 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for HF - Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 at 1 site in Spain.
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 6 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention). The study lists 13 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 6 Mar 2026.