HF - Heart Failure
Conditions
Keywords
Cardiopulmonary exercise testing- CPET, Metabolic Exercise Cardiac Kidney Indexes (MECKI) score
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 combined with Cardiac and Kidney Indexes (MECKI) score is one of the 3 HF prognostic models recommended by the 2021 European HF guidelines and it is considered the most powerful prognostic tool available. MECKI score integrates cardiopulmonary exercise test (CPET) data with easy-to-obtain clinical, laboratory, and echocardiographic variables. It is based on 6 parameters: peak oxygen intake (peakVO2), minute ventilation/carbon dioxide production (VE/VCO2 slope), hemoglobin (Hb), Left Ventricle Ejection Fraction (LVEF), kidney function by Modification of Diet in Renal Disease (MDRD) formula, and sodium (Na+). The aim of the present project is to assess the day-by-day MECKI score variability, CPET parameters interobserver variability, characterization of HF patients who change MECKI score values in 6 and 12 months, and the prognostic meaning of time dependent MECKI score changes.
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 participant center will perform patients' recruitment and follow up. At the baseline visit, CPET-related variables, echocardiographic, ECG, therapy and blood chemistry data will be collected. The baseline CPET will be repeated within 2 weeks. Patients will perform 4 follow up visits at 6, 12, 18 and 24 months after the baseline visit. At every study step, study procedures aimed to calculate MECKI score will be performed: * Echocardiography (Left Ventricle Ejection Fraction - LVEF) * Blood sample (Na+, MDRD, Hb) * Maximal ramp protocol CPET (peakVO2, minute ventilation/carbon dioxide production (VE/VCO2) slope - VE/VCO2 slope)
Interventions
DIAGNOSTIC_TESTCPET and related variables evaluation
At the baseline visit ,CPET-related variables, echocardiographic, ECG, therapy and blood chemistry data will be collected. The baseline CPET will be repeated within 2 weeks. Patients will perform 4 follow up visits at 6, 12, 18 and 24 months after the baseline visit. At every study step, it will be performed: * Echocardiography (LVEF) * Blood sample (Na+, MDRD, Hb) * Maximal ramp protocol CPET (peakVO2, VE/VCO2 slope)
Sponsors
Federico II University
Fondazione Toscana Gabriele Monasterio
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Centro Cardiologico Monzino
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Day-by-day variability of MECKI score | through study completion, an average of 3 year | Day by day variability of MECKI score will be done by comparing MECKI score value obtained at study run-in (day 0) and in a second evaluation of MECKI score performed within 2 weeks. |
| Identification of interobserver variability | through study completion, an average of 3 year | CPET interobservers variability will be done by assessing CPET analysis done by two recognized CPET experts blinded on patients data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-related dynamic changes of MDRD | through study completion, an average of 3 year | Modifications of MDRD in 6-12-18-24 months will be evaluated in relation to prognosis |
| Time-related dynamic changes of LVEF | through study completion, an average of 3 year | Modifications of LVEF in 6-12-18-24 months will be evaluated in relation to prognosis |
| Time-related dynamic changes of hemoglobin | through study completion, an average of 3 year | Modifications of hemoglobin in 6-12-18-24 months will be evaluated in relation to prognosis |
| Time-related dynamic changes of peak oxygen intake (VO2) | through study completion, an average of 3 year | Modifications in peak oxygen intake (VO2) in 6-12-18-24 months will be evaluated in relation to prognosis |
| The identification of the prognostic meaning of MECKI score changes at 6 months | 6 months | Modifications of MECKI score at 6 months will be evaluated in relation to prognosis |
| The identification of the prognostic meaning of MECKI score changes at one year | one year | Modifications of MECKI score at one year will be evaluated in relation to prognosis |
| Time-related dynamic changes of Na+ | through study completion, an average of 3 year | Modifications of Na+ in 6-12-18-24 months will be evaluated in relation to prognosis |
| Time-related dynamic changes of minute ventilation/carbon dioxide production (VE/VCO2) slope | through study completion, an average of 3 year | Modifications in minute ventilation/carbon dioxide production (VE/VCO2) slope in 6-12-18-24 months will be evaluated in relation to prognosis |
Countries
Italy
Contacts
Primary ContactPiergiuseppe Agostoni, Prof
Backup ContactElisabetta Salvioni, PhD
Outcome results
None listed