A Phase 4 interventional study of Methylprednisolone and Placebo in Heart Block, Aortic Stenosis and Bundle-Branch Block, sponsored by Hospital General Universitario de Alicante. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Hospital General Universitario de Alicante · Phase 4, Interventional, and Prevention
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in patients undergoing transaortic valve replacement compared to placebo. Participants randomized to the intervention group will receive a single dose of intravenous Methylprednisolone 7 mg/kg/day on the day of the procedure (1 hour before), followed by 15 mg/12 hours of daily Prednisone for 5 days.
The primary endpoint is a composite of permanent pacemaker implantation and the occurrence of new conduction abnormalities (any-degree AV block, bundle branch block, or non-specific intraventricular conduction disorder) at discharge, at 30 days and 1 year.
Aortic stenosis is the most common valvular heart disease in Europe, and its prevalence is expected to increase in the coming years. The definitive treatment is aortic valve replacement through surgery or transcatheter aortic valve implantation (TAVR). TAVR emerged as an alternative to surgery for high-surgical-risk patients, but it has also proven effective in intermediate or low surgical-risk cases, leading to an expected rise in procedures in the near future. The most frequent complication is atrioventricular block (AVB) and permanent pacemaker implantation (PPM), which has been associated with increased morbidity, hospital stay, and healthcare costs. However, it has been suggested that post-TAVR AVB may be a transient process due to the inflammatory response triggered by the procedure. Treating this inflammation could reduce the risk of AVB after TAVR, potentially benefiting both the economy and patient outcomes.
The investigators propose a phase IV, single-center, randomized, controlled trial with an unmasked evaluator to evaluate the effect of glucocorticoids on the prevention of conduction abnormalities and PPM in TAVR patients. 100 patients will be recruited (50 in the control group and 50 in the intervention group) undergoing TAVR at the General University Hospital Dr. Balmis in Alicante, excluding those with prior PPM, chronic corticosteroid treatment, or any contraindications to these drugs. The intervention group will receive a single dose of intravenous Methylprednisolone 7 mg/kg/day on the day of the procedure (1 hour before), followed by 15 mg/12 hours of daily Prednisone for 5 days. The inflammatory response and the occurrence of conduction abnormalities will be assessed through blood tests, electrocardiograms, and echocardiography. Data will be processed using IBM-SPSS version 25.0 statistical software.
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 59 interventional studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Hospital General Universitario de Alicante is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Compared within Bundle-Branch Block, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Block. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Methylprednisolone
Saline solution (0.9%)
Other: Placebo
The intervention group will recieve 7 mg/kg/day (or a maximum of 500 mg/day) of intravenous Methylprednisolone an hour before TAVR followed by 15 mg / 12h of Prednisone during 5 days after the intervention (starting 24h after the administration of Methylprednisolone).
Saline solution
Also known as: Saline solution
Number of patients that requiere pacemaker implantation and/or who develop new conduction abnormalities (AV block, bundle branch block, and/or non-specific intraventricular conduction disorder).
Time frame: One week, 30 days, and 1 year after admission
All-cause mortality
Time frame: One week, 30 days, and 1 year after admission
Incidence of strokes (ischemic, hemorrhagic, and/or other unspecified types)
Time frame: One week, 30 days, and 1 year after admission
Incidence of bleeding events requiring transfusion or life-threatening bleeding (BARC 3 or 5)
Time frame: One week after admission
Incidence of major vascular complications
Time frame: One week and 30 days after admission
Length of hospital stay
Time frame: One week after admission
Rate of adverse events related to the use of glucocorticoids
Number of episodes of hyperglycemia, hypertensive crisis, acute decompensated heart failure and local and systemic infections
Time frame: One week and 30 days after admission
Pacemaker dependency in patients who have undergone pacemaker implantation
Percentage of stimulation
Time frame: At 30 days and one year after admission
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Studies of the drug tested here: Methylprednisolone
Hospital General Universitario de Alicante