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A randomised double-blind placebo controlled trial of cardiovascular risk reduction during bereavement

A randomised double-blind placebo controlled trial of cardiovascular risk reduction during bereavement

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001387213
Acronym
CARBER 2
Enrollment
85
Registered
2018-08-17
Start date
2011-03-10
Completion date
2015-10-23
Last updated
2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the present project is to investigate whether individuals in early bereavement can reduce cardiovascular risk by taking therapy (beta-blocker and aspirin)

Interventions

Active treatment: metoprolol 25mg and aspirin 100mg Daily treatment for 6 weeks Administered as one daily tablet each of metoprolol 25mg and aspirin 100mg or one tablet each of the corresponding placebos. Adherence was monitored by drug table return.

Sponsors

Royal North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Spouses, partners or parents of patients who die in hospital; intensive care units, wards, emergency rooms, or are dead on arrival

Exclusion criteria

Active malignancy or any severe illness, respiratory, heart, liver, renal failure, coagulopathy, thrombocytopenia, cognitive impairment, psychotic illness, immunosuppressive illness or taking immunosuppressive drugs, nursing home residents or cannot speak or read English. We will further exclude people taking beta blockers, heart rate lowering calcium channel blockers, aspirin or with resting systolic BP<120mmHg or heart rate <60bpm, or with contraindication to aspirin or beta blockers, including peptic ulcer, asthma, unstable diabetes mellitus, or known allergy to these drugs. Withdrawal: Subjects will be withdrawn at the project investigator's discretion, including if it is considered that participatiing in the study is causing undue psychological distress, or at the subjects request.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026