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

Diabetic Kidney Disease Clinical Trial

— BENCH  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03105219
• Other study ID #: NFH20170403
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 1, 2017
• Est. completion date: May 30, 2021

Study information

• Verified date: November 2020
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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);

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Heart Diseases
• Kidney Diseases
• Myocardial Ischemia

Intervention

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.

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).

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary albumin excretion	Urinary albumin excretion at 3 month	3 month
Secondary	Serum creatinine	Serum creatinine at 3 month	3 month
Secondary	Blood urea nitrogen	Blood urea nitrogen at 3 month	3 month
Secondary	Cyscatin-c	Cyscatin-c at 3 month	3 month
Secondary	Hypersensitive c-reactive protein (hsCRP)	Hypersensitive c-reactive protein (hsCRP) at 3 month	3 month
Secondary	ß2-microglobulin	ß2-microglobulin at 3 month	3 month
Secondary	Neutrophil gelatinase-associated lipocalin(NGAL)	Neutrophil gelatinase-associated lipocalin(NGAL) at 3 month	3 month
Secondary	Albuminuria and urine creatinine ratio (ACR)	Albuminuria and urine creatinine ratio (ACR) at 3 month	3 month
Secondary	N-acyl-ß-D-glucosidase	N-acyl-ß-D-glucosidase at 3 month	3 month
Secondary	Retinol binding protein	Retinol binding protein at 3 month	3 month