Clinical trial NCT06313684: Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure
Official title: Comprehensive Hybrid Cardiac Rehabilitation Trial to Assess Impact on Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure NYHA Class II
Heart Failure NYHA Class III
Keywords: cardiac rehabilitation
heart failure
exercise
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
Collaborators: name: University of Chile
First posted: 2024-03-15
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 a week for the 2nd and 3rd months
* Owns a mobile phone
* Patient consents to participate in the study by signing an informed consent form.

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 3 months.
* 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 performing exercise.

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Baseline, 6 months and 12 months.
measure: Functional capacity
timeFrame: Baseline, 6 months and 12 months.
measure: Health Related Quality of Life
timeFrame: Baseline, 6 months and 12 months.
Secondary outcomes:
measure: Program adherence and completion
timeFrame: 6 months
measure: Concentration of Pro-B-type Natriuretic Peptide
timeFrame: Baseline, 6 months and 12 months.
measure: Functioning
timeFrame: Baseline, 6 months and 12 months.
measure: Mortality and Hospital admission
timeFrame: 12 months
measure: Upper-body muscle strength
timeFrame: Baseline, 6 months and 12 months.
measure: Lower-body muscle strength
timeFrame: Baseline, 6 months and 12 months.
measure: Cost
timeFrame: 6 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Complejo Hospitalario San José
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
city: Santiago
country: Chile
facility: Hospital San Borja Arriarán
city: Temuco
country: Chile
facility: Universidad de La Frontera
Study officials:
affiliation: Universidad de La Frontera
name: Pamela Seron, PhD
role: PRINCIPAL_INVESTIGATOR
References: