Effects of a Supervised Training Program on Functional Capacity in Patients With HF and Cardiorenal Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación para la Investigación del Hospital Clínico de Valencia

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Supervised aerobic plus strength training

Treatment groups

26 Participants
are divided into 2 treatment groups