September 6, 2024Hypertension ResearchOpen Access

Effects of spironolactone on exercise blood pressure in patients at increased risk of developing heart failure: report from the HOMAGE trial

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Why the study?

Previous spironolactone trials in heart failure did not assess exercise blood pressure responses, and reported conflicting results for exercise capacity.

Does spironolactone added to usual treatment reduce exercise blood pressure and improve exercise capacity in patients at increased risk of developing heart failure?

Structured PICO

Does spironolactone added to usual treatment reduce exercise blood pressure and improve exercise capacity in patients at increased risk of developing heart failure?

Population

227 patients aged ≥60 years at increased risk of developing heart failure (due to coronary heart disease or likely to develop it, with NT-proBNP 125-1000 ng/L or BNP 35-280 ng/L) who completed the incremental shuttle walk test at baseline, month 1, and month 9.

Intervention

Spironolactone 25-50 mg/day added to usual treatment

Comparator

Usual treatment alone (control)

Outcome

Blood pressure (BP) responses to exercise (pre- and post-exercise systolic/diastolic BP) and exercise capacity (number of completed shuttles) at months 1 and 9surrogate

In patients at increased risk of developing heart failure, spironolactone significantly reduced pre- and post-exercise blood pressure but did not improve exercise capacity or quality of life.

Limitations

Excluded patients who did not complete three ISWTs (at months 0, 1, and 9)
Lack of statistical power for completed shuttles and QoL due to small sample size (only 227 of 527 HOMAGE patients analyzed)
Follow-up not longer than 9 months

Implication

Spironolactone lowers exercise BP without improving capacity or QoL; leaves open its role in exertional hemodynamics for HF prevention.

Abstract

None of the spironolactone trials in heart failure (HF) assessed the blood pressure (BP) responses to exercise, while conflicting results were reported for exercise capacity. In the HOMAGE trial, 527 patients at increased HF risk were randomized to usual treatment with or without spironolactone (25-50 mg/day). The current substudy included 113 controls and 114 patients assigned spironolactone, who all completed the incremental shuttle walk test at baseline and months 1 and 9. Quality of life (QoL) was assessed by EQ5D questionnaire. Between-group differences (spironolactone minus control [Δs]) were analyzed by repeated measures ANOVA with adjustment for baseline and, if appropriate, additionally for sex, age and body mass index. Δs in the pre-exercise systolic/diastolic BP were -8.00 mm Hg (95% CI, -11.6 to -4.43)/-0.85 mm Hg (-2.96 to 1.26) at month 1 and -9.58 mm Hg (-14.0 to -5.19)/-3.84 mm Hg (-6.22 to -1.47) at month 9. Δs in the post-exercise systolic/diastolic BP were -8.08 mm Hg (-14.2 to -2.01)/-2.07 mm Hg (-5.79 to 1.65) and -13.3 mm Hg (-19.9 to -6.75)/-4.62 mm Hg (-8.07 to -1.17), respectively. For completed shuttles, Δs at months 1 and 9 were 2.15 (-0.10 to 4.40) and 2.49 (-0.79 to 5.67), respectively. Δs in QoL were not significant. The correlations between the exercise-induced BP increases and the number of completed shuttles were similar in both groups. In conclusion, in patients at increased risk of developing HF, spironolactone reduced the pre- and post-exercise BP, but did not improve exercise capacity or QoL.