Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06169345
Other study ID # LOCOMOTRI STUDY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date February 1, 2023

Study information

Verified date December 2023
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date February 1, 2023
Est. primary completion date August 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: 1. Patients with an echocardiographic diagnosis of moderate TR 2. Patients with echocardiographic and clinical follow-up information available at least 6-months after moderateTR diagnosis. Exclusion Criteria: 1. Absence of an appropriate clinical and echocardiographic follow-up 2. A history of previous TV intervention (either surgical or percutaneous) 3. The presence of concomitant TV stenosis 4. Congenital heart disease 5. Left ventricular assist devices

Study Design


Intervention

Other:
Echocardiographic evaluation
Echocardiographic follow-up

Locations

Country Name City State
Italy Irccs San Raffaele Milan

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause death Time from diagnosis to all-cause death through study completion, an average of 2 years
Secondary Cardiovascular (CV) mortality The occurrence of cardiovascular (CV) mortality (defined as death due to advanced heart failure, coronary ischemic heart disease, sudden cardiac death or due to stroke through study completion, an average of 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy