Treatment with Risedronate for dilated cardiomyopathy due to Troponin T alteration due to K210 deletion.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

8 Apr 2025 → ongoing

Decision date (initial)

2024-08-26

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Servicio de Cardiología HCUVA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To study whether the administration of Risedronate 10 mg/day in patients with dilated cardiomyopathy due to K210 deletion mutation in the Troponin T gene is associated with: A change in left ventricular function, measured by Echocardiogram

Secondary objectives 2

1. To study whether the administration of Risedronate 10 mg/day is associated with: Improvement in functional capacity, measured in the stress test with consumption of oxygen.
2. To study whether the administration of Risedronate 10 mg/day is associated with: Safety and tolerance in this population.

Conditions and MedDRA coding

Dilated cardiomyopathy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Older than 18 years old
2. Dilated cardiomyopathy due to K210 deletion mutation in the Troponin T gene
3. LVEF ≤ 50%
4. Patients who have given written informed consent

Exclusion criteria 9

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in LVEF, measured by echocardiography, at 6 months.

Secondary endpoints 1

1. Improvement in functional capacity, measured in the stress test with oxygen consumption, at 6 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Sponsor organisation

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Address

Carretera De Cartagena S/n, El Palmar El Palmar

City

Murcia

Postcode

30120

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Contact name

María Muñoz García

Public contact point

Organisation

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Contact name

María Muñoz García

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications