IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease

Study Overview
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Brief Summary
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To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.

Detailed Description
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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).

Official Title
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IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease

Conditions
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Diabetic Kidney Disease

Intervention / Treatment
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* Drug: Ivabradine
* Other: Sham Comparator


Participation Criteria
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Eligibility Criteria
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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);
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivabradine<br>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. | Drug: Ivabradine<br>* 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.<br>|
| Sham Comparator: Sham Comparator<br>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). | Other: Sham Comparator<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary albumin excretion | Urinary albumin excretion at 3 month | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine | Serum creatinine at 3 month | 3 month | 
| Blood urea nitrogen | Blood urea nitrogen at 3 month | 3 month | 
| Cyscatin-c | Cyscatin-c at 3 month | 3 month | 
| Hypersensitive c-reactive protein (hsCRP) | Hypersensitive c-reactive protein (hsCRP) at 3 month | 3 month | 
| β2-microglobulin | β2-microglobulin at 3 month | 3 month | 
| Neutrophil gelatinase-associated lipocalin(NGAL) | Neutrophil gelatinase-associated lipocalin(NGAL) at 3 month | 3 month | 
| Albuminuria and urine creatinine ratio (ACR) | Albuminuria and urine creatinine ratio (ACR) at 3 month | 3 month | 
| N-acyl-β-D-glucosidase | N-acyl-β-D-glucosidase at 3 month | 3 month | 
| Retinol binding protein | Retinol binding protein at 3 month | 3 month |