Hydroxychloroquine in Colchicine-Resistant Glucocorticoid-Dependent Idiopathic Recurrent Pericarditis

NCT05737680 | Unknown Phase 3

• 1 other identifier: RESTORE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Among patients with colchicine-resistant glucocorticoid-dependent idiopathic RP (idiopathic recurrent pericarditis during at least a second recurrence, having met the 2015 European Society of Cardiology criteria for pericarditis at least once), HCQ 400mg daily is associated with a reduce the risk of recurrence. The above hypothesis will be tested with a randomized, prospective, parallel, open label clinical trial. The expected study duration is approximately 12 months from the time the first subject is enrolled (planned for February 2023) to the time of study's termination date (December 2024). The researchers will obtain approval by the institutional review board (IRB).

Conditions

Pericarditis Idiopathic Recurrent

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate

  The diagnosis of RP in a patient with history of a documented episode of acute pericarditis according to ESC guidelines was established in the presence of at least 2 of the following conditions: i. pleuritic chest pain, ii. pericardial friction rub, iii. ECG compatible with acute pericarditis and iv. first detected or increasing in size pericardial effusion. C-reactive protein (CRP) elevation was considered a confirmatory finding. Since RP frequently underlines a secondary etiology, an extensive work-up was performed to exclude such diseases. In particular, apart from the first line evaluation, second level investigations were additionally performed such as thyroid function tests, chest and abdominal computed tomography, serological screening for autoimmune disorders, serum tumor markers and QuantiFERON-Tuberculosis Gold test.

  12 months follow-up

Secondary Outcomes (7)

• Time to Pericarditis Recurrence

  12 months follow-up

• Dose of the Corticosteroid in the time of the recurrence

  12 months follow-up

• State-Trait Anxiety Inventory (STAI)

  3,6,9,12 months follow-up

• Change over time of pericardial pain

  3,6,9,12 months follow-up

• Change over time of C-reactive protein levels

  3,6,9,12 months follow-up

Study Arms (2)

Hydroxychloroquine arm

ACTIVE COMPARATOR

Hydroxychloroquine 400mg daily

Drug: Hydroxychloroquine

Colchicine arm

ACTIVE COMPARATOR

Colchicine continued

Drug: Colchicine

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine 400mg daily

Hydroxychloroquine arm

Colchicine DRUG

Colchicine continued

Colchicine arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged≥18 years
• Idiopathic recurrent pericarditis with at least 2 recurrences
• Recurrent pericarditis defined as a first episode of acute pericarditis followed by recurrences (at least two recurrences for this study). First episode of pericarditis is diagnosed when at least two of the following criteria were present: pericarditis typical chest pain (sharp and pleuritic, improved by sitting up and leaning forward), pericardial friction rubs, widespread ST segment elevation or PR interval (PR) depressions not previously reported, and new or worsening pericardial effusion. Recurrence is diagnosed when chest pain recurs and one or more of the following signs is present: fever, pericardial friction rub, ECG changes, echocardiographic evidence of new or worsening pericardial effusion, and elevations in the white blood cell count, erythrocyte sedimentation rate or C-reactive protein. To be enrolled in this study, elevation of C-reactive protein is mandatory both in the first attack and in the following recurrences. The investigators differentiate recurrences from incessant pericarditis, term used to define patients with continued activity of pericarditis (with a symptom-free interval of \< 6 weeks)
• Specific aetiologies excluded, including tuberculous, neoplastic or purulent aetiologies, post-cardiac injury syndromes, and rheumatic autoimmune diseases.
• Female subjects must be postmenopausal, or incapable of pregnancy or permanently sterile, or if of childbearing potential must agree to use highly-effective method of contraception.
• Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule.

You may not qualify if:

• Ophthalmologic contraindications
• Structural heart disease
• Corrected QT interval \>440msec in men and \>450msec in women
• Left ventricular hypertrophy \>13mm in men and \>11mm in woman
• Known allergy or intolerance to hydroxychloroquine
• Life expectancy of \< 12 months
• Complex congenital heart disease
• History of ventricular arrhythmias other than isolated extrasystoles
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
• Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
• On the heart transplant list

Sponsors & Collaborators

• Hippocration General Hospital: lead

Study Sites (1)

"Hippokration" General Hospital of Athens

Athens, Attica, 11527, Greece

Location

MeSH Terms

Interventions

Hydroxychloroquine; Colchicine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Alkaloids

Central Study Contacts

George Lazaros, MD, PhD, FESC

CONTACT

+30‭6974389238‬; glaz35@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Konstantinos P. Tsioufis, MD, PhD, FESC, FACC, Professor of Cardiology, Director of 1st Department of Cardiology, Hippokratio Hospital, University of Athens

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 21, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

GR (1)