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

Nanjing First Hospital, Nanjing Medical University

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Diabetic Kidney Disease

Interventions

IvabradineDRUG

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.

Sham ComparatorOTHER

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).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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);

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Urinary albumin excretion

Urinary albumin excretion at 3 month

Time frame: 3 month

Secondary Outcomes

Serum creatinine

Serum creatinine at 3 month

Time frame: 3 month

Blood urea nitrogen

Blood urea nitrogen at 3 month

Time frame: 3 month

Cyscatin-c

Cyscatin-c at 3 month

Time frame: 3 month

Hypersensitive c-reactive protein (hsCRP)

Hypersensitive c-reactive protein (hsCRP) at 3 month

Time frame: 3 month

β2-microglobulin

β2-microglobulin at 3 month

Time frame: 3 month

Neutrophil gelatinase-associated lipocalin(NGAL)

Neutrophil gelatinase-associated lipocalin(NGAL) at 3 month

Time frame: 3 month

Albuminuria and urine creatinine ratio (ACR)

Albuminuria and urine creatinine ratio (ACR) at 3 month

Time frame: 3 month

N-acyl-β-D-glucosidase

N-acyl-β-D-glucosidase at 3 month

Time frame: 3 month

Retinol binding protein

Data from ClinicalTrials.gov

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