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

Phase 3

Withdrawn

• Conditions: Diabetic Kidney Disease
• Interventions: Other: Sham Comparator; Drug: Ivabradine

• Registration Number: NCT03105219
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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).

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Study Start: 2017-07-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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;

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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);

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Comparator	Sham 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).
Ivabradine	Ivabradine	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.

Primary Outcome Measures

Name	Time	Method
Urinary albumin excretion	3 month	Urinary albumin excretion at 3 month

Secondary Outcome Measures

Name	Time	Method
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
β2-microglobulin	3 month	β2-microglobulin 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
Serum creatinine	3 month	Serum creatinine at 3 month
N-acyl-β-D-glucosidase	3 month	N-acyl-β-D-glucosidase at 3 month
Retinol binding protein	3 month	Retinol binding protein at 3 month

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China