Clinical trial • Phase IV • Cardiology | Rare Disease

Risedronate sodium for Dilated cardiomyopathy | Dilated cardiomyopathy due to Troponin T K210 deletion

Phase IV trial of Risedronate sodium for Dilated cardiomyopathy | Dilated cardiomyopathy due to Troponin T K210 deletion. 5 participants.

Overview

Trial Therapeutic Area: Cardiology | Rare Disease
Trial Disease: Dilated cardiomyopathy | Dilated cardiomyopathy due to Troponin T K210 deletion
Trial Stage: Phase IV
Drug Modality: Small molecule

Phase IV trial across 1 site in Spain.

Recruits 5 No vulnerable populations selected; participants must be older than 18 years and provide written informed consent..

Pregnancy Exclusion: Pregnant or breastfeeding women
Vulnerable Population: No vulnerable populations selected; participants must be older than 18 years and provide written informed consent.

{"criterion_text":"-Older than 18 years old"}
{"criterion_text":"-Dilated cardiomyopathy due to K210 deletion mutation in the Troponin T gene"}
{"criterion_text":"-LVEF ≤ 50%"}
{"criterion_text":"-Patients who have given written informed consent"}

{"criterion_text":"-Hypersensitivity to Risedronate"}
{"criterion_text":"-Hypocalcemia"}
{"criterion_text":"-Severe renal failure (eGFR < 30 ml/min/1.73m2)"}
{"criterion_text":"-History of esophageal disorders, with delay in transit or esophageal emptying, due to example, stenosis or achalasia"}
{"criterion_text":"-Barrett's esophagus"}
{"criterion_text":"-Inability to remain upright for at least 30 minutes after taking of the tablet."}
{"criterion_text":"-Active treatment with corticosteroids or chemotherapy"}
{"criterion_text":"-Pregnant or breastfeeding women"}
{"criterion_text":"-Use of other investigational drugs at the time of inclusion, or during the 30 days prior to inclusion"}

{"endpoint_text":"-Change in LVEF, measured by echocardiography, at 6 months.","definition_or_measurement_approach":"Left ventricular ejection fraction (LVEF) assessed by echocardiography at 6 months"}

{"endpoint_text":"-Improvement in functional capacity, measured in the stress test with oxygen consumption, at 6 months.","definition_or_measurement_approach":"Functional capacity measured by exercise/stress test with oxygen consumption (VO2) at 6 months"}

Planned Sample Size: 5
Recruitment Window Months: 24
Consent Approach: Participants must provide written informed consent; adults only (>18). No further details on assent, age-specific documents, or languages specified.

Full Name: Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
Organisation Type: Educational Institution
Country Of Registered Address: Spain

{"country":"","full_name":"Servicio de Cardiología HCUVA","duties_or_roles":"Monetary support","organisation_type":""}

Investigational Product Name: Actonel 5 mg comprimidos recubiertos con película
Active Substance: Risedronate sodium
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: Oral
Authorisation Status: Marketing authorisation (marketingAuthNumber: 63.208; authorisationCountryCode: ES)
Starting Dose: 10 mg/day
Dose Levels: 10 mg
Frequency: Daily
Maximum Dose: 10 mg/day; max total 3650 mg

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