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Screening-guided spironolactone treatment of subclinical left ventricular dysfunction for heart failure prevention in
Elizabeth Potter1,2, Georgia Stephenson1, Joanne Harris1
1Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.
Insights
Screening for subclinical left ventricular dysfunction (LVD) and treating with spironolactone did not prevent heart failure (HF) in at-risk older adults. However, spironolactone did improve LVD in patients who completed the treatment.
Area of Science:
- Cardiology
- Geriatrics
- Pharmacology
Background:
- Subclinical left ventricular dysfunction (LVD) often precedes symptomatic heart failure (HF).
- Early intervention in at-risk populations may prevent HF progression.
- Spironolactone is a potential therapeutic agent for LVD.
Purpose of the Study:
- To investigate if echocardiography-guided spironolactone treatment prevents incident HF in asymptomatic older adults with risk factors.
- To assess the effect of spironolactone on LVD and functional capacity.
Main Methods:
- Randomized trial of 349 asymptomatic individuals aged ≥65 years with HF risk factors.
- Intervention group received spironolactone guided by echocardiographic LVD criteria; control group received usual care.
- Primary outcome: incident HF at 24 months. Secondary outcomes: 6-minute walk test (6MWT) and left ventricular function changes.
Main Results:
- The trial was stopped early due to high spironolactone discontinuation rates (55%), mainly from renal function decline.
- No significant difference in incident HF between groups (2.5% vs 4.7%, p=0.29).
- Per-protocol analysis showed LVD resolution in 59% of spironolactone-treated patients vs. 33% of controls (p=0.01).
Conclusions:
- Screening-guided spironolactone therapy was underpowered to show HF prevention due to treatment discontinuation.
- Spironolactone demonstrated a benefit in resolving LVD in patients who tolerated the medication.
- Future trials should consider less stringent renal criteria for spironolactone discontinuation.
Aims:
Subclinical left ventricular dysfunction (LVD) is a prelude to symptomatic heart failure (HF). We hypothesised that screening-guided treatment with spironolactone would prevent incident HF in at-risk patients.
Methods And Results:
We randomised asymptomatic, community-dwelling subjects aged ≥65 years old, with at least one non-ischaemic HF risk factor (hypertension, type 2 diabetes mellitus or obesity) to echocardiography-guided therapy or usual care. Spironolactone therapy was triggered by the detection of subclinical LVD (global longitudinal strain [GLS] ≤16%) or diastolic abnormalities (at least one of E/e' >15, E/e' >10 with left atrial enlargement [LAE] or impaired relaxation [E/A < 0.8, IR], LAE with IR), or borderline GLS (17%) with IR or borderline GLS with LAE. The primary outcome was incident HF at 24 months. Secondary outcomes were change in 6-min walk test (6MWT) and change in left ventricular function. LVD was identified in 161 (46%) of 349 participants (age 70 [68-73] years, 201 [58%] women). The trial was stopped because of a 55% rate of spironolactone discontinuation, due primarily to decline in renal function. Incident HF developed in 11 (3.5%) of 310 participants completing follow-up, with no difference between usual care and intervention (4 [2.5%] vs. 7 [4.7%], p = 0.29), decline in 6MWT distance (p = 0.28), persistent or new LVD (p = 0.58), nor change in GLS with intervention (p = 0.15). A per-protocol analysis of 131 patients with baseline LVD and a follow-up echocardiogram, showed resolution of LVD with spironolactone therapy (59% vs. 33%, p = 0.01).
Conclusion:
The study was underpowered to determine whether screening-guided spironolactone therapy reduced incident HF because spironolactone was frequently discontinued due to renal function criteria. However, LVD resolved in more patients treated with spironolactone than in untreated patients. Future trials should use less conservative renal criteria for spironolactone discontinuation.
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