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

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

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Kidney Disease
• Intervention / Treatment: Drug: Ivabradine; Other: Sham Comparator

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
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).	Other: 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: NFH20170403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes