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

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.

NCT Number	NCT06640140
Lead Sponsor	Fundación para la Investigación del Hospital Clínico de Valencia
Conditions	Heart Failure, Cardiorenal Syndrome
Enrollment	26 participants
Start Date	2024-10-08
Primary Completion	2025-09 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-10-15