Bromocriptine effect on left ventricular hypertrophy in patients with diabetic nephropathy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000779077

Acronym

BELVHD

Enrollment

Registered

2010-09-20

Start date

2004-11-19

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Left ventricular hypertrophy (LVH) is a major cardiovascular risk factor in patients with diabetic nephropathy and chronic kidney disease (CKD), it predicts myocardial infarction, stroke and cardiovascular death. The prevalence of LVH increases as the renal function declines. High blood pressure, obesity and abnormal lipid profile which often coexist with diabetes have an important role in its development. The mechanism by which LVH develops includes activation of the renin-angiotensin system, aldosterone secretion, and sympathetic over activity. Bromocriptine a DA2 receptor agonist inhibits norepinephrine release and decrease blood pressure acting at the presynaptic receptors. In the kidney it mediates vasodilatation and decreases tubular sodium reabsorption, it also decreases the expression of type-1 angiotensin II receptors in renal proximal tubule and inhibits aldosterone secretion. All of these actions could exert an antiproliferative effect on LVH and modulate kidney function. The objective of this study was to analyze the effect of bromocriptine on left ventricular hypertrophy and its influence in residual renal function in patients with diabetic nephropathy, LVH and stage IV of CKD.

Interventions

Bromocriptine oral tablets 2.5 mg or bromocriptine placebo oral tablets 2.5 mg . The daily doses administered were as follows: Week 1: 1x2.5 mg oral tablet per day, taken after the night meal;Week 2: 2 x 2.5 mg oral tablets per day (5 mg), taken in the morning meal and after the night meal; Weeks 3 - 24 : 3 x 2.5 mg oral tablets per day (7.5 mg) taken after meals. The subjects received this medication in addition to their current treatment.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

type 2 diabetes mellitus Left ventricular mass > or = 116 g/m2in men and 104 g/m2 in women. Creatinine clearance < or =30 ml/min. 24h Ambulatory blood pressure (AMBP) > or = 130/80 mmHg. Patients who give written informed consent

Exclusion criteria

Patients treated with dopamine (DA2) receptors antagonists. Cardiac insuficiency. Cardiac stroke.

Outcome results