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Search / Trial NCT06313684

Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure

Launched by UNIVERSIDAD DE LA FRONTERA · Mar 8, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Cardiac Rehabilitation Heart Failure Exercise

ClinConnect Summary

The CO-CREATION-HF trial is looking to see how well a new type of heart rehabilitation program works for people with heart failure compared to just supervised exercise. This program combines different approaches to help patients improve their heart health and overall well-being. The trial is currently recruiting participants aged 65 to 74 who are in stable condition and have heart failure classified as NYHA Class II or III, meaning they experience some limitations in physical activity but are not severely affected.

To join the study, candidates must have been on the right medications for their heart failure and be able to attend sessions at a health center three times a week for the first month and twice a week for the next two months. Participants will need to have a mobile phone and agree to be part of the study by signing a consent form. It's important to note that some people may not be eligible, like those with severe kidney disease, certain heart conditions, or other serious health issues that could prevent them from safely participating in exercise. If you or a loved one are interested, this trial could offer a valuable opportunity to improve heart health in a supportive environment.

Gender

ALL

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.

About Universidad De La Frontera

Universidad de la Frontera is a distinguished academic institution dedicated to advancing health sciences through innovative research and clinical trials. Located in Chile, the university fosters a collaborative environment that integrates multidisciplinary expertise to address pressing health challenges. With a commitment to ethical standards and patient safety, Universidad de la Frontera actively engages in clinical research aimed at improving healthcare outcomes and contributing valuable insights to the global medical community. Its robust research infrastructure and emphasis on education position it as a leader in the field of clinical trials and translational medicine.

Locations

Temuco, , Chile

Santiago, , Chile

Santiago, , Chile

Santiago, , Chile

Patients applied

0 patients applied

Trial Officials

Pamela Seron, PhD

Principal Investigator

Universidad de La Frontera

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported