Evaluating heart failure prognosis using the MECKI score
A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
NA · Centro Cardiologico Monzino · NCT06070519
This study is trying to see if a new scoring system can help doctors better predict the health of people with stable heart failure by looking at their exercise test results and other health information over two years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino (other) |
| Locations | 4 sites (Milano, Milan and 3 other locations) |
| Trial ID | NCT06070519 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the precision of prognosis in stable heart failure patients by utilizing the Metabolic Exercise Cardiac Kidney Indexes (MECKI) score, which integrates data from cardiopulmonary exercise testing (CPET) with clinical, laboratory, and echocardiographic variables. The study will assess the variability of the MECKI score over time and the interobserver variability of CPET parameters. Participants will undergo a baseline evaluation followed by multiple follow-up visits over two years to monitor changes in their MECKI score and related health metrics. The study is designed as a low-intervention multicenter trial, involving several medical centers for patient recruitment and follow-up.
Who should consider this trial
Good fit: Ideal candidates include individuals with a history or presence of heart failure symptoms and a left ventricular ejection fraction of less than 40%.
Not a fit: Patients with significant comorbidities affecting exercise performance or those scheduled for major cardiovascular interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and personalized prognosis for heart failure patients, potentially improving management and outcomes.
How similar studies have performed: Other studies have shown success with similar prognostic approaches in heart failure, indicating the potential effectiveness of the MECKI score.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milano, Milan and 3 other locations
- IRCCS Centro Cardiologico Monzino — Milano, Milan, Italy (RECRUITING)
- Università di Napoli Federico II — Napoli, Italy (RECRUITING)
- Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione — Palermo, Italy (NOT_YET_RECRUITING)
- Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica — Pisa, Italy (RECRUITING)
Study contacts
- Principal investigator: Piergiuseppe Agostoni, Prof — IRCCS Centro Cardiologico Monzino
- Study coordinator: Piergiuseppe Agostoni, Prof
- Email: piergiuseppe.agostoni@cardiologicomonzino.it
- Phone: 02 58002586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HF - Heart Failure, Cardiopulmonary exercise testing- CPET, Metabolic Exercise Cardiac Kidney Indexes score