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

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03105219
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 46.9
• Patients Per Site Per Month: 0

Study Details

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.

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 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
• Anticipated Study Start Date: Jul 1, 2017
• Anticipated Primary Completion Date: May 30, 2021
• Anticipated Study Completion Date: May 30, 2021

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Urinary albumin excretion [3 month]

   Urinary albumin excretion at 3 month

Secondary Outcome Measures

1. Serum creatinine [3 month]

   Serum creatinine at 3 month

2. Blood urea nitrogen [3 month]

   Blood urea nitrogen at 3 month

3. Cyscatin-c [3 month]

   Cyscatin-c at 3 month

4. Hypersensitive c-reactive protein (hsCRP) [3 month]

   Hypersensitive c-reactive protein (hsCRP) at 3 month

5. β2-microglobulin [3 month]

   β2-microglobulin at 3 month

6. Neutrophil gelatinase-associated lipocalin(NGAL) [3 month]

   Neutrophil gelatinase-associated lipocalin(NGAL) at 3 month

7. Albuminuria and urine creatinine ratio (ACR) [3 month]

   Albuminuria and urine creatinine ratio (ACR) at 3 month

8. N-acyl-β-D-glucosidase [3 month]

   N-acyl-β-D-glucosidase at 3 month

9. Retinol binding protein [3 month]

   Retinol binding protein at 3 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Type 2 diabetes and coronary heart disease;
• 1. Urinary albumin excretion: 30-500mg/24h;
• 1. Sinus rhythm, and resting heart rate ≥ 70bpm;

Exclusion Criteria:

• 1. Renal dysfunction defined as eGFR < 30ml/min/1.73m^2;
• 1. Atrial flutter, and atrial fibrillation;
• 1. Resting heart rate < 70bpm;
• 1. Combined with non-dihydropyridine CCB;
• 1. UAE<30mg/24h, or > 500mg/24h;
• 1. Acute heart failure;
• 1. Low blood pressure (BP<90/50mmHg);
• 1. Acute myocardial infarction (<14 days);

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital	Nanjing	Jiangsu	China	210006

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT03105219
• Other Study ID Numbers: NFH20170403
• First Posted: Apr 7, 2017
• Last Update Posted: Nov 9, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Kidney Diseases; Diabetic Nephropathies; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia

Study Results

No Results Posted as of Nov 9, 2020