Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidad Pontificia Comillas | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remote ischemic preconditioning | Experimental | Participants randomized to the remote ischemic preconditioning intervention group will receive a hand-held blood pressure device (Welch Allyn DuraShockâ„¢ 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic preconditioning | Procedure | Participants randomized to the remote ischemic preconditioning intervention group will receive a hand-held blood pressure device (Welch Allyn DuraShockâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Comorbidity that may influence prognosis at one year.
Participation in another clinical trial
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iván | Cuenca | Cuenca | 16001 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided