NCT05537194

Brief Summary

Due to their effects on hypoxic pulmonary vasoconstriction (HPV), dihydropyridine calcium channel inhibitors (CCI) could lead to hypoxia in patients with a pulmonary shunt. To the present time only preclinical studies and case reports focused on this potential adverse drug reaction. We aimed to assess the reporting association between CCI and hypoxia using the World Health Organization pharmacovigilance database (VigiBase®).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1963

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1963

Completed
59.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

59.7 years

First QC Date

September 8, 2022

Last Update Submit

September 8, 2022

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

  • association between dihydropyridine CCI or urapidil and hypoxia

    from the 01/01/1963 to the 14/08/2022

Study Arms (2)

Patients with hypoxia

Drug: dihydropyridine calcium channel inhibitors use

Patients without hypoxia

Drug: dihydropyridine calcium channel inhibitors use

Interventions

dihydropyridine calcium channel inhibitors useDRUG

administration of dihydropyridine calcium channel inhibitors

Patients with hypoxiaPatients without hypoxia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Reports in VigiBase

You may qualify if:

  • present in the database

You may not qualify if:

  • chronology not compatible with the drug imputability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 13, 2022

Study Start

January 1, 1963

Primary Completion

August 14, 2022

Study Completion

August 14, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations

FR(1)