Supervised aerobic plus strength training: Supervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training.
Study summary
This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)\] of 26 patients (13 per arm) would be necessary to test our hypothesis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients diagnosed with heart failure according to 2021 ESC guidelines for Heart Failure.
* Evidence of cardiorenal syndrome, defined as coexistent very high risk chronic kidney disease (CKD) (estimated glomerular filtration rate \[eGFR\] \<30 ml/min/1.73m2 or eGFR 30 to 44 ml/min/1.73m2 and Urine Albumin-Creatinine Ratio \[uACR\] \>30 mg/g) or rapidly progressive CKD (loss of \>5 ml/min/1.73m2 in one year).
* Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month.
* Age ≥ 18 years old.
* Willing to provide written informed consent.
Exclusion Criteria:
* Inability to perform a valid baseline cardiopulmonary exercise test.
* Significant primary severe valve disease that is considered the main symptom driver.
* Effort angina or signs of ischemia during CPET.
* Primary cardiomyopathies.
* Cardiac transplantation.
* Any other comorbidity with a life expectancy of less than one year.
Primary outcome measure(s)
Peak oxygen consumption — The investigators will evaluate peak oxygen consumption at baseline (week 0) and at week 12. Primary outcome: changes in peak oxygen consumption between groups at 12 weeks.
Description:
Peak oxigen consumption (also known as maximal functional capacity) will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a semi-supine bicycle ergometer (coupled with stress echocardiography), beginning with a workload of 10 Watts and increasing gradually in a ramp protocol at 10-Watts increments every 1 minute. Peak oxygen consumption (PeakVO2) is defined as the highest value of VO2 during the last 20 seconds of exercise.
Unit of measure of peak oxygen consumption: mL/kg/min (this is a directly reported measure from the cardiopulmonary exercise testing, not an aggregated or derived calculation).
Trial sites (1)
Facility
City
Region
Status
Instituto de investigación sanitaria INCLIVA
Valencia
Spain
More Fundación para la Investigación del Hospital Clínico de Valencia trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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