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A randomized controlled study for nicorandil on improving coronary microcirculation dysfunction in patients with myocardial hypertrophy after aortic valve replacement

Effect of nicorandil on coronary microcirculation in patients with myocardial hypertrophy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023816
Enrollment
Unknown
Registered
2019-06-13
Start date
2019-06-17
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myocardial hypertrophy

Interventions

control group:routine antiheart failure drug treatment
experimental group:nicorandil combined with routine antiheart failure drug treatment

Sponsors

General Hospital of Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) 18-80 years of age, regardless of gender; 2) patients with simple aortic valve disease; 3) Cardiac echocardiography on the 7th day after valve surgery revealed myocardial hypertrophy, and the patients with LVEF between 0.3 and 0.45 were measured by Simpson method. 4) Contrast agents myocardial filling defect existed in the left ventricular wall by myocardial contrast echocardiography, but it had no significant relationship with the blood supply area of coronary artery branches, mainly in the middle segment of left ventricular wall and apex. 5) Patients who are stable enough to be discharged after routine anti-heart failure treatment; 6) The person or his legal representative consented and signed the Informed Consent.

Exclusion criteria

Exclusion criteria: 1) Coronary angiography in patients over 40 years of age suggests that CABG should be performed concurrently; 2) Allergic to nicorandil, nicotinic acid or contrast agent; 3) Glaucoma; 4) Therapeutic agents for erectile dysfunction(sildenafil citrate, vardenafil nicotinate hydrate, tadalafil) with phosphodiesterase-5 blocking effect are being taken; 5) Nicorandil was used within 7 days before selection; 6) Severe heart failure, grade III or above of cardiac function; 7) Systolic blood pressure < 90 mmHg; 8) Severe bradycardia (heart rate < 50 beats/min) or II~III degree atrioventricular block; 9) Atrial fibrillation or flutter; 10) History of asthma or severe COPD; 11) eGFR < 30 ml/min; 12) Abnormal platelet count or coagulation dysfunction; 13) History of malignant tumors or autoimmune diseases; 14) Severe infection; 15) Decompensated period of liver and kidney insufficiency; 16) Necessary use of nitrates for coronary artery dilatation; 17) Researchers found it difficult to follow up (travel, speech or mental disorders, etc.); 18) Participating in another interventional clinical study.

Design outcomes

Primary

MeasureTime frame
improvement rate of peak rate of contrast agents in the same section of myocardium;

Secondary

MeasureTime frame
NT-proBNP;Evaluation of Cardiac Function Grading;Left ventricular ejection fraction;End-diastolic diameter of left ventricle;Left ventricular diastolic function classification;

Countries

China

Contacts

Public ContactYan Jin

General Hospital of Northern Theater Command

jinyan4158@vip.sina.com+86 13309888850

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026