What is the clinical evidence from this study?

Study design: RCT. Population: myocardial infarction (n=542). Intervention: Nisoldipine coat-core vs. Placebo. Primary outcome: Exercise time at 6 months.

What does this research mean for the field?

Nisoldipine-CC does not improve exercise time in post-myocardial infarction patients with impaired left ventricular function, but it delays exercise-induced ischemia and improves diastolic left ventricular function. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To determine the effect of nisoldipine coat-core on exercise capacity, ischemic thresholds, and left ventricular function in patients recovering from myocardial infarction.

August 14, 2026European Heart JournalOpen Access

Doppler flow and echocardiography in functional cardiac insufficiency: Assessment of nisoldipine therapy: Results of the DEFIANT-II study

Q: What are the key findings of this study?

Nisoldipine-CC did not improve exercise time compared to placebo, but prolonged time to 1 mm ST deviation (P=0.03) and improved early peak velocity by 3.6 cm/s (P=0.01).

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Key result

Nisoldipine-CC fails to improve exercise time vs placebo but prolongs time to ST deviation.

n=542

Why the study?

The study was conducted to evaluate the effect of nisoldipine coat-core on exercise capacity in patients after myocardial infarction.

Does nisoldipine-CC improve exercise time in patients 7-10 days post-myocardial infarction with LVEF 25-50% and no heart failure?

Population

542 post-myocardial infarction patients with LVEF 25-50% and no heart failure

Comparison

Nisoldipine coat-core vs placebo

Design

Multicentre double-blind placebo-controlled randomized trial

Follow-up

6 months

Discussion

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Implication

Nisoldipine-CC failed to improve post-MI exercise capacity; leaves open potential diastolic or ischemic benefits for targeted trials.

Key Points

To determine the effect of nisoldipine coat-core on exercise capacity, ischemic thresholds, and left ventricular function in patients recovering from myocardial infarction.
Multicentre, double-blind, placebo-controlled trial enrolling 542 patients randomized 7 to 10 days post-myocardial infarction with left ventricular ejection fraction between 25% and 50% without overt heart failure.
Patients received nisoldipine coat-core (nisoldipine-CC) or placebo for 6 months.
Assessed exercise duration, time to 1 mm ST deviation, Doppler echocardiography metrics, and adverse cardiac outcomes.
Total exercise time did not differ between treatment groups, but nisoldipine-CC significantly extended time to 1 mm ST deviation (P = 0.03).
Nisoldipine-CC improved diastolic markers, increasing early peak velocity by +3.6 cm/s (P = 0.01) and shortening isovolumic relaxation time by -6.2 ms (P = 0.005), without altering ejection fraction or LV volumes.
All-cause mortality was 1 death in the nisoldipine-CC arm versus 7 in the placebo arm (P < 0.07), while peripheral edema occurred in 49 nisoldipine-CC patients versus 2 placebo patients (P < 0.001).

Study Design

Type

RCT (n=542)

Blinding

Double-blind

Randomization

randomized

Multicenter

Yes

Structured PICO

Does nisoldipine-CC improve exercise time in patients 7-10 days post-myocardial infarction with LVEF 25-50% and no heart failure?

Population

542 patients randomized 7-10 days after myocardial infarction with reduced left ventricular ejection fraction (25-50%) but no heart failure, followed for 6 months.

Intervention

Nisoldipine coat-core (nisoldipine-CC) for 6 months

Comparator

Placebo

Outcome

Exercise time after 6 monthssurrogate

In post-MI patients with asymptomatic LV dysfunction, nisoldipine-CC did not improve exercise time but improved diastolic left ventricular function and delayed exercise-induced ischemia.

Cite This Study

A 1997 study conducted an RCT in myocardial infarction (n=542). Nisoldipine coat-core vs. Placebo was evaluated on Exercise time at 6 months. Nisoldipine-CC did not improve exercise time compared to placebo, but prolonged time to 1 mm ST deviation (P=0.03) and improved early peak velocity by 3.6 cm/s (P=0.01).

synapsesocial.com/papers/6a7ea950ec5eed42c5a78d00 https://doi.org/10.1093/oxfordjournals.eurheartj.a015115

Topics

Heart failure HFrEF treatment

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Doppler flow and echocardiography in functional cardiac insufficiency: Assessment of nisoldipine therapy: Results of the DEFIANT-II study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

Topics

Doppler flow and echocardiography in functional cardiac insufficiency: Assessment of nisoldipine therapy: Results of the DEFIANT-II study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

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Topics

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