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

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ClinicalTrials.gov Identifier: NCT03105219
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Shaoliang Chen, 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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Ivabradine Other: Sham Comparator Phase 3

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  (Clinical Trial)
Estimated Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Urinary albumin excretion at 3 month
Primary Purpose: Treatment
Official Title: IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivabradine

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).




Primary Outcome Measures :
  1. Urinary albumin excretion [ Time Frame: 3 month ]
    Urinary albumin excretion at 3 month


Secondary Outcome Measures :
  1. Serum creatinine [ Time Frame: 3 month ]
    Serum creatinine at 3 month

  2. Blood urea nitrogen [ Time Frame: 3 month ]
    Blood urea nitrogen at 3 month

  3. Cyscatin-c [ Time Frame: 3 month ]
    Cyscatin-c at 3 month

  4. Hypersensitive c-reactive protein (hsCRP) [ Time Frame: 3 month ]
    Hypersensitive c-reactive protein (hsCRP) at 3 month

  5. β2-microglobulin [ Time Frame: 3 month ]
    β2-microglobulin at 3 month

  6. Neutrophil gelatinase-associated lipocalin(NGAL) [ Time Frame: 3 month ]
    Neutrophil gelatinase-associated lipocalin(NGAL) at 3 month

  7. Albuminuria and urine creatinine ratio (ACR) [ Time Frame: 3 month ]
    Albuminuria and urine creatinine ratio (ACR) at 3 month

  8. N-acyl-β-D-glucosidase [ Time Frame: 3 month ]
    N-acyl-β-D-glucosidase at 3 month

  9. Retinol binding protein [ Time Frame: 3 month ]
    Retinol binding protein at 3 month



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105219


Contacts
Contact: Shaoliang Chen, MD +86-25-52208351 chmengx@126.com
Contact: Jing Kan, MPH +86-25-52271398 kanjingok@126.com

Locations
China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Junjie Zhang, PHD    86-25-52271350    jameszll@163.com   
Contact: Xiaofei Gao, MD    86-25-52271350    gaoxiaofei2014@163.com   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
Study Chair: Shaoliang Chen, MD Nanjing First Hospital, Nanjing Medical University

Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03105219     History of Changes
Other Study ID Numbers: NFH20170403
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Urologic Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases