Status:
RECRUITING
A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
Lead Sponsor:
Centro Cardiologico Monzino
Collaborating Sponsors:
Federico II University
Fondazione Toscana Gabriele Monasterio
Conditions:
HF - Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The project is dedicated to the improvement of our capability to provide a precise and personalized prognosis in heart failure (HF) patients in stable conditions. The Metabolic Exercise test data comb...
Detailed Description
This is a low-intervention multicenter clinical trial aim at evaluating the role of time dependent prognostic parameters changes, moving from the single shot evaluation to dynamic analysis. Each parti...
Eligibility Criteria
Inclusion
- Previous or present HF symptoms (NYHA functional class I-IV, stage B and C of ACC/AHA classification)
- history or presence of left ventricular ejection fraction (LVEF)\<40%
- unchanged HF medications for at least three months
- ability to perform a CPET
- no major cardiovascular treatment or intervention scheduled
Exclusion
- History of pulmonary embolism
- moderate-to-severe aortic and mitral stenosis
- pericardial disease
- severe obstructive lung disease
- exercise-induced angina
- significant ECG alterations, or presence of any clinical comorbidity interfering with exercise performance
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06070519
Start Date
May 1 2023
End Date
May 1 2026
Last Update
October 6 2023
Active Locations (4)
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1
IRCCS Centro Cardiologico Monzino
Milan, Milan, Italy, 20138
2
Università di Napoli Federico II
Napoli, Italy, 80138
3
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo, Italy, 90127
4
Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica
Pisa, Italy, 56124