Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

Last updated: November 27, 2024
Sponsor: Universidad de La Frontera
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Hyponatremia

Treatment

Initial Assessment

Interval Exercise

Psychosocial support

Clinical Study ID

NCT06313684
Fondecyt 1230787
  • Ages > 18
  • All Genders

Study Summary

CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with HF of New York Heart Association functional class II or III.

  • Meets HF diagnostic criteria of Guidelines

  • On optimal tolerated medical therapy.

  • Deemed by the treating physician as stable for at least 1 month.

  • Able to attend the health center three times a week for the first month, and twice aweek for the 2nd and 3rd months

  • Owns a mobile phone

  • Patient consents to participate in the study by signing an informed consent form.

Exclusion

Exclusion Criteria:

  • Chronic kidney disease with glomerular filtration rate < 20 mL/min.

  • Decompensated thyroid disease.

  • End-stage liver failure or Child-Pugh C.

  • Cardiac device or cardiac surgery in the previous month or planned in the next 3months.

  • Patients with dyspnea predominantly of non-cardiac cause (e.g. COPD).

  • Atrial fibrillation with a heart rate greater than 90 beats per minute at rest.

  • Active neoplasm with life expectancy <2 years.

  • Inclusion in another interventional study.

  • Explicit contraindications to performing exercise.

  • Comorbidities that preclude the patient from engaging in a CR program.

  • Musculoskeletal or neurological disease that precludes the patient from performingexercise.

Study Design

Total Participants: 152
Treatment Group(s): 8
Primary Treatment: Initial Assessment
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
March 31, 2027

Study Description

Comprehensive, hybrid cardiac rehabilitation (CR) models have been scantly investigated in heart failure (HF) populations, particularly in low-resource settings.

A 2 parallel-arm, multi-center randomized clinical superiority trial will be conducted with blinded outcome assessment. 152 HF patients (NYHA class II or III) will be recruited consecutively, and randomly assigned. The experimental intervention will include evaluation, medical and nurse management, aerobic interval training, resistance exercise, psychosocial support, and education. These will initially be delivered in a center, transitioning to home in 4 stages. Participants in the control arm will receive face-to-face continuous aerobic exercise sessions and resistance exercises. The main outcomes are cardiorespiratory fitness, functional capacity, and quality of life. These will be measured at baseline, end of intervention, and 12-month follow-up.

The pragmatic, comprehensive hybrid CR model could be implemented more broadly if superiority is demonstrated.

Connect with a study center

  • Complejo Hospitalario San José

    Santiago,
    Chile

    Active - Recruiting

  • Hospital Clínico Universidad de Chile

    Santiago,
    Chile

    Active - Recruiting

  • Hospital San Borja Arriarán

    Santiago,
    Chile

    Active - Recruiting

  • Universidad de La Frontera

    Temuco,
    Chile

    Active - Recruiting

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