Calcium Channel Blockers and Angiotensin Converting Enzyme Inhibitors for Heart Disease Prevention in Systemic Sclerosis
This observational study aims to monitor the combined usage of Calcium Channel Blockers and Angiotensin Converting Enzyme Inhibitors in preventing heart disease in individuals with Systemic Sclerosis, focusing on occurrences of cardiac blocks, ventricular arrhythmias, pacemaker implantation, congestive heart failure, and sudden death.
Data Collection
Collected from today forward - ProspectiveCardiac Conduction System Disease+9
+ Cardiovascular Diseases
+ Connective Tissue Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.Systemic sclerosis is a rare condition that impacts the connective tissue of the skin and various internal organs. One of the complications of this disease is heart involvement, which can lead to heart rhythm issues, heart failure, and even sudden death. Currently, there's no proven medication to treat heart disease associated with systemic sclerosis. However, some short-term studies and retrospective analyses suggest that calcium channel blockers and angiotensin converting enzyme (ACE) inhibitors might have a positive effect. This study is part of a larger project called 'DeSScipher', which aims to understand the best ways to manage systemic sclerosis. This particular trial focuses on evaluating the effectiveness and safety of calcium channel blockers and ACE inhibitors in asymptomatic systemic sclerosis patients with heart involvement. In this observational study, participants with systemic sclerosis and heart involvement will be monitored. The study aims to measure the cumulative occurrence of heart-related issues such as heart rhythm disturbances, heart failure, and sudden death. It also tracks the need for pacemaker implantation. The study does not involve any new treatments, rather it observes the participants' health over time to understand the potential benefits and risks associated with using calcium channel blockers and ACE inhibitors.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.765 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Juvenile and adult systemic sclerosis patients, with diagnosis according to the SSc ACR/EULAR criteria or the PRES/ACR/EULAR juvenile SSc criteria respectively Asymptomatic (for cardiac disease) systemic sclerosis patients at risk for severe heart disease with at least one of the following risk factors: male sex and/or DLCO lower than 80% and/or sPAP > 30 mmHg and/or synovitis and/or joint contractures and/or digital ulcers and/or proteinuria. Asymptomatic for cardiac disease is defined by patients without dyspnea NYHA >/= II, without palpitations and without bilateral leg edema. Exclusion Criteria: Any significant pulmonary parenchymal (FVC < 70% and/or DLCO < 70%), pulmonary vascular (estimated systolic PAP > 40 mmHg), gastrointestinal (malabsorption syndrome or paralytic ileus) or renal (serum creatinine level >1.2 mg/dl, dialysis or previous scleroderma renal crisis) involvement Patients with dyspnea class NYHA >/= II Patients with palpitations Patients with bilateral leg edema.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, FranceOpen Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 in Google MapsJustus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, GermanyCharité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, GermanyCentre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, Germany