NCT07365501

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Oct 2025Feb 2027

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

January 16, 2026

Last Update Submit

March 4, 2026

Conditions

HF - Heart Failure

Outcome Measures

Primary Outcomes (13)

  • Systolic Blood Pressure

    he maximum arterial pressure during ventricular systole, measured at the brachial artery by the Mobil-O-Graph using oscillometric technology.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline, 0 Minutes post intervention, 30 minutes post intervention, 60 minutes post intervention and 24 hours post intervention

Study Arms (2)

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.

Procedure: remote ischemic preconditioning

No remote ischemic preconditioning

NO INTERVENTION

No intervention

Interventions

remote ischemic preconditioningPROCEDURE

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.

remote ischemic preconditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iván

Cuenca, Cuenca, 16001, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

ES(1)