NCT05162742 (CHIANTI) is a Phase 3 clinical trial of Colchicine in Aortic Valve Disease, sponsored by Radboud University Medical Center.

Who is sponsoring NCT05162742?

NCT05162742 is sponsored by Radboud University Medical Center.

What drugs are being tested in NCT05162742?

Interventions in NCT05162742: Colchicine, Placebo.

What condition does NCT05162742 study?

NCT05162742 studies Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Inflammation, Calcification, Cardiovascular Diseases.

Is NCT05162742 still recruiting?

NCT05162742 is currently active, enrolled. Last updated 11 September 2025.

Last reviewed 2025-09-11 · How we verify

NCT05162742: CHIANTI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Colchicine and Inflammation in Aortic Stenosis

Active, enrolled Phase 3 Last updated 11 September 2025

What this trial tests

Phase 3 trial testing Colchicine in Aortic Valve Disease in 150 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 December 2022

Primary endpoint
22 December 2025

22 December 2025

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	150
Start date	22 December 2022
Primary completion	22 December 2025
Estimated completion	22 December 2025
Sites	1 location across Netherlands

Drugs / interventions tested

Colchicine (COLCHICINE) — full drug profile →
Placebo

Conditions studied

Aortic Valve Disease — all drugs for Aortic Valve Disease →
Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
Aortic Valve Calcification — all drugs for Aortic Valve Calcification →
Inflammation — all drugs for Inflammation →

Sponsor

Radboud University Medical Center

Who can join

Adults 50 to 80, any sex, with Aortic Valve Disease or Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Unraveling the Mechanisms of Valvular Heart Disease to Identify Medical Therapy Targets: A Scientific Statement From the American Heart Association.
Small AM, Yutzey KE, Binstadt BA, Voigts Key K, et al · · 2024 · cited 40× · PMID 38881493 · DOI 10.1161/cir.0000000000001254
Calcific aortic stenosis: omics-based target discovery and therapy development.
Blaser MC, Bäck M, Lüscher TF, Aikawa E. · · 2025 · cited 13× · PMID 39656785 · DOI 10.1093/eurheartj/ehae829
Circulating neutrophil-related proteins associate with incident heart failure and cardiac dysfunction: The ARIC study.
Buckley LF, Dorbala P, Claggett BL, Libby P, et al · · 2023 · cited 12× · PMID 37608611 · DOI 10.1002/ejhf.3008
Effects of interventions targeting the systemic inflammatory response to cardiac surgery on clinical outcomes in adults.
Abbasciano RG, Tomassini S, Roman MA, Rizzello A, et al · · 2023 · cited 7× · PMID 37873947 · DOI 10.1002/14651858.cd013584.pub2
Anti-inflammatory pharmacotherapy in patients with cardiovascular disease.
Finocchiaro S, Mazzone PM, Ammirabile N, Bordonaro C, et al · · 2025 · cited 6× · PMID 40828623 · DOI 10.1093/ehjcvp/pvaf058
The Haemodynamic and Pathophysiological Mechanisms of Calcific Aortic Valve Disease.
Hanna L, Armour C, Xu XY, Gibbs R. · · 2022 · cited 4× · PMID 35740339 · DOI 10.3390/biomedicines10061317
Navigating the Landscape of Translational Medicine of Calcific Aortic Valve Disease: Bridging Bench to Bedside.
Qian X, Xu L, Geng B, Li F, et al · · 2025 · cited 2× · PMID 40180541 · DOI 10.1016/j.jacasi.2025.01.014
The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial.
Mohammadnia N, Vestjens LTW, Craig NJ, Tijssen JGP, et al · · 2025 · cited 1× · PMID 40659197 · DOI 10.1016/j.ahj.2025.07.010

Verify or expand the search:

Other trials of Colchicine

Trials testing the same drug.

NCT07476625 — Efficacy and Safety of Thalidomide for Pediatric PFAPA Syndrome · NA · not yet recruiting
NCT06279000 — Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery · Phase 3 · recruiting
NCT06813079 — Using Tumor Models to Determine Treatments · Phase 2 · not yet recruiting
NCT06578182 — The Effect of ColcHicine on the Incidence of Knee or Hip Replacements · Phase 3 · recruiting
NCT06203977 — Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR) · Phase 1 · recruiting

Other recruiting trials for Aortic Valve Disease

Currently open trials in the same condition.

NCT07008911 — CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation · NA · recruiting
NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting
NCT07021612 — A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Pa · recruiting
NCT06896227 — TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics · NA · recruiting
NCT06189976 — Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation · NA · recruiting

Other Radboud University Medical Center trials

Trials by the same sponsor.

NCT07485569 — Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial · Phase 1 · not yet recruiting
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NCT07530263 — Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) · Phase 1 · not yet recruiting
NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
NCT07504172 — Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05162742 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
Last refreshed: 11 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05162742.

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