Nicorandil improves exercise endurance in patients with chronic heart failure with preserved ejection fraction and coronary microcirculation dysfunction: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200067078

Enrollment

Unknown

Registered

2022-12-26

Start date

2023-01-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

heart failure with preserved ejection fraction

Interventions

nicorandil group:routine treatment+nicorandil

control gorup:routine treatment

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Age =18 and =80, male or female 2)CT load myocardial perfusion imaging (contrast-enhanced acoustics) suggests endothelial dependent dysfunction in coronary microvessels: CFR125pg/mL (sinus law) or >365pg/mL (atrial fibrillation), pulmonary artery systolic blood pressure =35mmHg, etc. 4) NYHA Class II-III 5) Coronary angiography or coronary CTA confirmed no severe epicardial coronary artery stenosis (diameter stenosis rate <50%). 6) The patient agreed to participate in the study to understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Acute myocarditis, pericardial disease, valvular heart disease, primary cardiomyopathy, congenital heart disease, primary pulmonary hypertension or secondary severe pulmonary hypertension 2) Had coronary artery bypass grafting or PCI; 3) Patients with haemodynamic disorder during acute heart failure within 1 month, or patients requiring mechanical ventilation and cardiac mechanical assistance 4) Abnormal liver function (serum ALT level is 3.0 times higher than the upper limit of normal) or abnormal kidney function (eGFR=30 ml/min/1.73m2) 5) People who are allergic to or have an adverse reaction to nicodil 6)Life expectancy is less than two years. 7) Pregnancy or lactation, or intention to give birth within one year, or use effective contraceptive measures during the childbearing period.

Design outcomes

Primary

Measure	Time frame
improvement in exercise endurance;	—

Secondary

Measure	Time frame
composite endpoints (all-cause death, admission for heart failure);coronary microcirculation;serum NT-proBNP levels;	—

Countries

China

Contacts

Public ContactGu Jun

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

forrestgu@126.com13917970451

Outcome results

None listed

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