Diabetic Kidney Disease
Conditions
Brief summary
To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.
Detailed description
This is a multi-center, randomized, open-label, investigator-initiated study with a parallel design. Patients with type 2 diabetes and coronary heart disease who are microalbuminuric \[urinary albumin excretion (UAE): 30-500 mg/day\], will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day. Group Β: Placebo. Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).
Interventions
DRUGIvabradine
Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.
OTHERSham Comparator
Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Urinary albumin excretion at 3 month
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 1\. Type 2 diabetes and coronary heart disease; * 2\. Urinary albumin excretion: 30-500mg/24h; * 3\. Sinus rhythm, and resting heart rate ≥ 70bpm;
Exclusion criteria
* 1\. Renal dysfunction defined as eGFR \< 30ml/min/1.73m\^2; * 2\. Atrial flutter, and atrial fibrillation; * 3\. Resting heart rate \< 70bpm; * 4\. Combined with non-dihydropyridine CCB; * 5\. UAE\<30mg/24h, or \> 500mg/24h; * 6\. Acute heart failure; * 7\. Low blood pressure (BP\<90/50mmHg); * 8\. Acute myocardial infarction (\<14 days);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary albumin excretion | 3 month | Urinary albumin excretion at 3 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | 3 month | Serum creatinine at 3 month |
| Blood urea nitrogen | 3 month | Blood urea nitrogen at 3 month |
| Cyscatin-c | 3 month | Cyscatin-c at 3 month |
| Hypersensitive c-reactive protein (hsCRP) | 3 month | Hypersensitive c-reactive protein (hsCRP) at 3 month |
| Retinol binding protein | 3 month | Retinol binding protein at 3 month |
| Neutrophil gelatinase-associated lipocalin(NGAL) | 3 month | Neutrophil gelatinase-associated lipocalin(NGAL) at 3 month |
| Albuminuria and urine creatinine ratio (ACR) | 3 month | Albuminuria and urine creatinine ratio (ACR) at 3 month |
| N-acyl-β-D-glucosidase | 3 month | N-acyl-β-D-glucosidase at 3 month |
| β2-microglobulin | 3 month | β2-microglobulin at 3 month |
Countries
China
Outcome results
None listed