Last reviewed · How we verify
NCT05376514: CAVE-ON
Central Blood Pressure and Variability Evaluation
trial in AAA in 137 participants. Completed in 30 June 2024.
30 June 2024
Quick facts
| Lead sponsor | Imperial College Healthcare NHS Trust |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 137 |
| Start date | 7 June 2022 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 2 locations across United Kingdom |
Conditions studied
- AAA — all drugs for AAA →
- Abdominal Aortic Aneurysm — all drugs for Abdominal Aortic Aneurysm →
- Blood Pressure — all drugs for Blood Pressure →
Sponsor
Imperial College Healthcare NHS Trust
Who can join
55 and older, any sex, with AAA or Abdominal Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: A sub-study of the AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) trial indicated a statistically significant association between central blood pressure (BP) variability and abdominal aortic aneurysm (AAA) growth. The role of anti-hypertensive adherence has not been explored in the context of AAA growth. Objective: To confirm whether higher central BP variability is associated with higher AAA growth rates and to examine the effect of medication adherence on AAA growth rates in a prospective longitudinal cohort study. Methods: Up to 175 patients will be recruited over ten months from two sites with standardised quality control of AAA, BP and antihypertensive non-adherence measurement. Patients (\>55 years), with AAAs ≥3cm in diameter (including AAA ≥5.5cm, not proceeding to surgery) will be recruited and undergo AAA ultrasound (US), BP (peripheral and central) and antihypertensive non-adherence measurements every four months (+/- one month) for 24 months. Ambulatory BP variability data will be collected. Data on medication adherence and beliefs around medications will be collected with validated questionnaires. Analysis: Primarily, the relationship between central diastolic BP visit-to-visit variability and AAA growth (estimated by multilevel modelling) based on US measurements and secondarily the relationship between central diastolic BP variability and time taken to reach the threshold for AAA repair (5.5 cm) or rupture.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05376514
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for AAA
Currently open trials in the same condition.
- NCT05133492 — First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA) · NA · active not recruiting
Other Imperial College Healthcare NHS Trust trials
Trials by the same sponsor.
- NCT07474584 — OpRESTORE AI-Patient Navigator Study · NA · not yet recruiting
- NCT07191678 — Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions · recruiting
- NCT06501846 — Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding. · NA · recruiting
- NCT04904484 — A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients · NA · unknown
- NCT06355570 — Delirium After Cardiac Surgery in Intensive Care Units · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05376514 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Imperial College Healthcare NHS Trust
- Last refreshed: 31 January 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/NCT05376514.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing