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Colchicine and Inflammation in Aortic Stenosis

Study acronym: CHIANTI
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 22, 2025 → Dec 2026
See other at-risk trials from Radboud University Medical Center

Record History

  1. Primary and study completion pushed from Dec 22, 2025 to Dec 2026v9
  2. Re-verified, no change to tracked fieldsv8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Primary and study completion dates: May 1, 2025 to Dec 22, 2025
    • Start date changed from estimate of Nov 1, 2022 to Dec 22, 2022
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jun 15, 2022 to Nov 1, 2022v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 1, 2022 to Jun 15, 2022
    • Site details revised
    v3
  3. Primary and study completion dates: Jan 1, 2024 to May 1, 2025
    • Start date: Jan 1, 2022 to May 1, 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aortic stenosis (AS) is the most common valvular heart disease in the developed world. Once symptomatic, untreated patients have a poor prognosis with five-year survival rate of 25%. Once at an advanced stage, AS will lead to the development of left ventricle hypertrophy, and eventually heart failure and death. At-present, there is no effective medical therapy for aortic stenosis. Current management of patients with AS consists of 'watchful waiting'. Valve replacement is needed when these patients (often acutely) become symptomatic. Recent studies have shown that inflammatory processes with similarities to atherosclerosis play an important role in AS. Therefore, we hypothesize that treatment with anti-inflammatory therapy, in the form of colchicine, could reduce the progression of AS. If positive, this trial will be the first to provide a potential therapeutic option for millions of people world-wide with AS.
Trial Details
NCT Number NCT05162742
Lead Sponsor Radboud University Medical Center
Conditions
(from sponsor)		 Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Inflammation, Calcification, Cardiovascular Diseases
Related terms Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve, Calcification of, Calcinosis, Cardiovascular Diseases, Inflammation
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov