Effects of a Supervised Training Program on Functional Capacity in Patients With HF and Cardiorenal Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supervised aerobic plus strength training.
- Who it may be relevant to
- Registry conditions: Heart Failure, Cardiorenal Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Cardiorenal Syndrome
Overview
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.
Detailed 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.
Interventions
- Behavioral Supervised aerobic plus strength training
Supervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training.
Primary outcome measures
- Peak oxygen consumption [Time frame: The investigators will evaluate peak oxygen consumption at baseline (week 0) and at week 12.]
Secondary outcome measures (2)
- Kansas City Cardiomyopathy Questionnaire [Time frame: The investigators will evaluate Kansas City Cardiomyopathy Questionnaire at baseline (week 0) and at week 12.]
- Chronotropic index [Time frame: The investigators will evaluate chronotropic index at baseline (week 0) and at week 12.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Instituto de investigación sanitaria INCLIVA — Valencia
Identifiers
NCT: NCT06640140 · Train-CR