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

Last updated: October 10, 2024
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

Supervised aerobic plus strength training

Clinical Study ID

NCT06640140
Train-CR
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with heart failure according to 2021 ESC guidelines for HeartFailure.

  • Evidence of cardiorenal syndrome, defined as coexistent very high risk chronickidney disease (CKD) (estimated glomerular filtration rate [eGFR] <30ml/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 oneyear).

  • Stable symptomatic heart failure patients (New York Heart Association functionalclass II-III/IV) during the last month.

  • Age ≥ 18 years old.

  • Willing to provide written informed consent.

Exclusion

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.

Study Design

Total Participants: 26
Treatment Group(s): 1
Primary Treatment: Supervised aerobic plus strength training
Phase:
Study Start date:
October 08, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Heart failure (HF) is a highly prevalent clinical entity that predominantly affects elderly people with comorbidities. Among these, chronic kidney disease is particularly frequent, complicating disease management and worsening prognosis. Supervised training programs in patients with HF have improved functional capacity and reduced hospitalizations. However, the evidence is scarce regarding the effects of a supervised training program on patients with HF and cardiorenal syndrome. This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HF and cardiorenal syndrome on peak oxygen consumption (peakVO2).

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.

Connect with a study center

  • Instituto de investigación sanitaria INCLIVA

    Valencia, 46010
    Spain

    Site Not Available

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