Second Australian National Blood Pressure Study (ANBP2): Effect of Angiotensin-Converting Enzyme (ACE) Inhibitor and Diuretic-based Treatment on rates of cardiovascular-associated mortality in the Elderly

Australian Comparative Trial of the effect of Angiotensin-Converting Enzyme (ACE) Inhibitor and Diuretic-based Treatment of Hypertension on rates of cardiovascular-associated mortality in the Elderly

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000398707

Acronym

ANBP2

Enrollment

6083

Registered

2022-03-08

Start date

1996-07-01

Completion date

2001-12-31

Last updated

2022-03-14

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

Conditions

None listed

Brief summary

To determine in hypertensive subjects of 65-84 years of age whether there is any difference in total cardiovascualr events (fatal and non-fatal) over a five year treatment period between antihypertensive treatment with ACE inhibitor-based regimen and treatment with a diuretic-based regimen.

Interventions

Dose: 5mg of ACE inhibitor enalapril as per GP's directions Duration: Life-long Mode: Oral tablet Once daily dose: Adherence monitored by GP questioning (no tablet returns or laboratory tests)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

65 Years to 84 Years

Healthy volunteers

Inclusion criteria

- Are 65-84 years of age - Confirmed hypertension, either untreated or previously treated, with average untreated sitting blood pressure on the 2nd and 3rd screening visits of the study greater than or equal to 160 mmHg or greater than or equal to90 mmHg diastolic (if systolic BP is greater than or equal to 140 mmHg) - Have no history of recent cardiovascular morbidity (see under exclusion criteria), serious intercurrent illness or a absolute contraindication to an ACE inhibitor or diuretic - Are capable of and willing to give informed consent - Are ambulant and able to attend their general practitioner's practise throughout the study

Exclusion criteria

- Prescence of any previous nonfatal cardiovascular event which defines an end-point for the study in the past 6 months. Refers to any existing condition (eg cancer) which the GP feels is likely to cause death with 5 years. - Accelerated or malignant hypertension - Dementia - Plasma creatinine concentration > 0.2mmol/l. The measurement should have been within the past 12 months or, if this is not available, will be undertaken at the initial screening visit - Any life threatening illness considered to be likely to cause death within the study's observation period (5 years) - Presence of any absolute contraindication to or specific indication for an ACE inhibitor or a diuretic - Consideration by the subject's general practitioner that the subject is unsuitable for the study

Outcome results