NCT07024810Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 30 May 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- University of Castilla-La Mancha
- Diseases
- Heart failure
- NCT number
- NCT07024810
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 1 Oct 2025 to the primary completion date, 28 Feb 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Signs of ischemia during maximal cardiopulmonary stress test.
- Comorbidity that may influence prognosis at one year.
- Participation in another clinical trial
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.