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

NCT06640140 | Not Yet Recruiting

• 1 other identifier: Train-CR
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Cardiorenal Syndrome

Keywords

Heart failure; Cardiorenal Syndrome; Functional Capacity

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption

  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).

  The investigators will evaluate peak oxygen consumption at baseline (week 0) and at week 12.

Secondary Outcomes (2)

• Kansas City Cardiomyopathy Questionnaire

  The investigators will evaluate Kansas City Cardiomyopathy Questionnaire at baseline (week 0) and at week 12.

• Chronotropic index

  The investigators will evaluate chronotropic index at baseline (week 0) and at week 12.

Other Outcomes (3)

• Age

  The investigators will evaluate age at baseline (week 0) and at week 12.

• Peak heart rate

  The investigators will evaluate peak heart rate at baseline (week 0) and at week 12.

• Heart rate at rest

  The investigators will evaluate heart rate at rest at baseline (week 0) and at week 12.

Study Arms (2)

Usual care

NO INTERVENTION

Patients allocated to this arm will receive the usual care plus explicit recommendations for home-based aerobic and strength training.

Supervised aerobic plus strenght training

ACTIVE COMPARATOR

Patients allocated to this arm will receive the usual care plus supervised aerobic and strength training.

Behavioral: Supervised aerobic plus strength training

Interventions

Supervised aerobic plus strength training BEHAVIORAL

Supervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training.

Supervised aerobic plus strenght training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Instituto de investigación sanitaria INCLIVA

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Heart Failure; Cardio-Renal Syndrome

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gonzalo Núñez Marín, MD

  Instituto de investigación sanitaria INCLIVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Fernández, PhD

CONTACT

961973536; patricia.fernandez@incliva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinded only for the evaluator of primary and secondary endpoints.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: October 8, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

ES (1)