Printed from Voxsanity (voxsanity.com.au) — NCT05292716 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Heart Disease
Heart Disease Trial, Recruiting
NCT05292716
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 90 years old
- You have a significant leaking mitral heart valve (a specific type called "secondary mitral regurgitation"), confirmed by heart scan at the end of the screening period
- You are already receiving the best available medicines for your heart condition, as recommended by current medical guidelines
- You have advanced heart failure with severe, ongoing symptoms (feeling very breathless or unable to do basic activities) despite taking those medicines
- Your heart's pumping ability is significantly reduced and/or you have high levels of certain proteins in your blood that indicate heart failure (BNP or NTproBNP), confirmed by tests
- Your quality of life is significantly affected (scored below 75 on a standard questionnaire), AND either you have very limited ability to exercise, OR you have had at least one unplanned hospital visit in the last 12 months due to heart failure needing emergency treatment through a drip
Who may not be able to join:
- Your mitral valve shape or size makes it unsuitable for a specific clip-based procedure (called MitraClip), in the opinion of the treating doctor
- A heart scan shows a mass, blood clot, or infection growth inside your heart
- You currently have an active heart valve infection or rheumatic heart disease, or your heart valves have been damaged by rheumatic disease
- You currently have an active infection being treated with antibiotics
- You are unable to safely have a special type of ultrasound scan performed through your throat (confirm with trial site)
- You have significant blocked heart arteries that have not yet been treated
- You have low iron levels in your blood, or you received an iron infusion in the last 30 days
- You have had certain heart procedures (bypass surgery, stenting, valve replacement, or heart rhythm device implantation) within the last 30 days
- You have had a heart rhythm procedure or electrical shock treatment to reset your heart rhythm within the last 30 days
- You have had a heart attack or stroke within the last 30 days
- Your blood pressure is dangerously low or you need machines or medicines to support your heart's function right now
- Your severe symptoms are mainly caused by a lung disease, cancer, or another serious non-heart condition
- You have a non-heart-related illness that means you are not expected to live for more than 12 months
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Not Applicable
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Registry
ClinicalTrials.gov
Start date
21 April 2021
Est. completion
21 April 2025
Where this trial is recruiting
🇮🇹 Italy
Primary endpoints
Absolute change in overall KCCQ summary score (KCCQ-OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.