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

Primary Purpose

Diabetic Kidney Disease

Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ivabradine
Sham Comparator
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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);

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ivabradine

Sham Comparator

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Urinary albumin excretion
Urinary albumin excretion at 3 month

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2017
Last Updated
November 5, 2020
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03105219
Brief Title
IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
Acronym
BENCH
Official Title
IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Shortfall in funding
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Urinary albumin excretion at 3 month
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Comparator
Intervention Description
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).
Primary Outcome Measure Information:
Title
Urinary albumin excretion
Description
Urinary albumin excretion at 3 month
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Serum creatinine
Description
Serum creatinine at 3 month
Time Frame
3 month
Title
Blood urea nitrogen
Description
Blood urea nitrogen at 3 month
Time Frame
3 month
Title
Cyscatin-c
Description
Cyscatin-c at 3 month
Time Frame
3 month
Title
Hypersensitive c-reactive protein (hsCRP)
Description
Hypersensitive c-reactive protein (hsCRP) at 3 month
Time Frame
3 month
Title
β2-microglobulin
Description
β2-microglobulin at 3 month
Time Frame
3 month
Title
Neutrophil gelatinase-associated lipocalin(NGAL)
Description
Neutrophil gelatinase-associated lipocalin(NGAL) at 3 month
Time Frame
3 month
Title
Albuminuria and urine creatinine ratio (ACR)
Description
Albuminuria and urine creatinine ratio (ACR) at 3 month
Time Frame
3 month
Title
N-acyl-β-D-glucosidase
Description
N-acyl-β-D-glucosidase at 3 month
Time Frame
3 month
Title
Retinol binding protein
Description
Retinol binding protein at 3 month
Time Frame
3 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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