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

Nanjing Medical University

Status and phase: Withdrawn; Phase 3

Conditions: Diabetic Kidney Disease

Treatments: Other: Sham Comparator; Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT03105219

NFH20170403

Details and patient eligibility

About

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

Full 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).

Sex: All

Volunteers: No 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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Ivabradine

Experimental group

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.

Treatment:

Drug: Ivabradine

Sham Comparator

Sham Comparator group

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).

Treatment:

Other: Sham Comparator