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

NCT ID: NCT03105219

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2021-05-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Diabetic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Urinary albumin excretion at 3 month

Study Groups

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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.

Group Type EXPERIMENTAL

Ivabradine

Intervention Type DRUG

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

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).

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type OTHER

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).

Interventions

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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.

Intervention Type DRUG

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).

Intervention Type OTHER

Eligibility Criteria

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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);
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shaoliang Chen

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaoliang Chen, MD

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NFH20170403

Identifier Type: -

Identifier Source: org_study_id