BridgeMD
Compares treatment options for Cardiomyopathy, Dilated
Official title Early Treatment With Candesartan vs Placebo in Genetic Carriers of Dilated Cardiomyopathy (EARLY-GENE Trial)
ClinicalTrials.gov ID: NCT05321875
What this study is testing
What is Candesartan?
Candesartan is an investigational medicine, being studied as a potential treatment for cardiomyopathy, dilated.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial to evaluate safety and efficacy of candesartan in the prevention of the development of Dilated Cardiomyopathy (DCM) in genetic carriers of a DCM-causing variant without disease expression (asymptomatic)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Age: 18-64 (both included), both sexes
- Carrier of a pathogenic or likely pathogenic DCM genetic variant1 according to modified American College of Medical Genetics (ACMG) criteria.
- Baseline LVEF ≥ 50% measured by MRI1 and evaluated by the eligibility study committee. Carriers with myocardial fibrosis, detected by late gadolinium...
- Baseline creatinine ≤1.3 mg/dL, potassium ≤ 5.3 mEq/L and an estimated Glomerular Filtration Rate (eGFR)≥ 60 ml/min/1.73 m2 calculated by CKD-EPI...
- Able to understand and accept the study constraints and to provide informed consent.
You likely can't join if
- Hypotension (systolic arterial pressure \<100 mmHg (measured following a standardized methodology).
- Prior ventricular dysfunction (LVEF ≤ 50% at any time prior to study inclusion)
- Candidates who are expected or highly likely to receive an implantable cardioverter defibrillator (ICD) in the following 12 months after inclusion in...
- Preexisting hypertension requiring pharmacological treatment.
- Uncontrolled arterial hypertension (i.e., repeatedly systolic arterial pressure \> 140 mmHg).
- Carriers of TTN-truncating variants (TTNtv) who are \< 35 years old.
See the full eligibility criteria
- Age: 18-64 (both included), both sexes
- Carrier of a pathogenic or likely pathogenic DCM genetic variant1 according to modified American College of Medical Genetics (ACMG) criteria.
- Baseline LVEF ≥ 50% measured by MRI1 and evaluated by the eligibility study committee. Carriers with myocardial fibrosis, detected by late gadolinium enhancement in magnetic resonance imaging, are valid.
- Baseline creatinine ≤1.3 mg/dL, potassium ≤ 5.3 mEq/L and an estimated Glomerular Filtration Rate (eGFR)≥ 60 ml/min/1.73 m2 calculated by CKD-EPI formula.
- Able to understand and accept the study constraints and to provide informed consent.
- Hypotension (systolic arterial pressure \<100 mmHg (measured following a standardized methodology).
- Prior ventricular dysfunction (LVEF ≤ 50% at any time prior to study inclusion)
- Candidates who are expected or highly likely to receive an implantable cardioverter defibrillator (ICD) in the following 12 months after inclusion in the trial
- Preexisting hypertension requiring pharmacological treatment.
- Uncontrolled arterial hypertension (i.e., repeatedly systolic arterial pressure \> 140 mmHg).
- Carriers of TTN-truncating variants (TTNtv) who are \< 35 years old.
- Known clinically significant coronary artery disease (e.g., ≥70% stenosis in any epicardial artery or ≥50% of left main coronary artery), valvular disease (≥ moderate in severity) or ventricular arrhythmias.
- Ongoing treatment with ACEI, ARB, ARNI or MRA.
- Prior intolerance to ACE inhibitors or ARB.
- Presence of any contraindications to receive candesartan treatment, including severe liver failure and/or cholestasis
- Known bilateral renal artery stenosis.
- Uncontrolled concomitant severe disease (e.g., with expected survival inferior to the duration of the study follow-up)
- Participation in any other clinical trial using an investigational medicinal product or device in the 30 days previous to the inclusion in the study.
- Current pregnancy, breastfeeding or women of childbearing age who are not willing to practice an adequate birth control during the entire duration of the study (a negative pregnancy test result must be confirmed at the...
- Drug or alcohol abuse (current).
- Inability to comply with study procedures and treatments.
- Carriers of MRI incompatible internal devices (ICD, pacemakers, aneurysm clips, etc.), with known intolerance to MRI studies or presenting any contraindications to perform cardiac MRI studies.
- Any circumstances that in the investigator's opinion compromise the participant's ability to participate in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Majadahonda, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Majadahonda, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.