Kurrelmeyer 2014.
| Methods |
Study design: parallel RCT Centres: 1 hospital, Houston, Texas Start of enrolment: 2004 End of enrolment: 2008 Follow‐up: 6 months Run‐in period: "patients were treated with 25 mg open‐label spironolactone for 1 week before randomization to ensure drug tolerability, defined as serum potassium < 5 mEq/L and absence of other major side effects." |
|
| Participants |
Inclusion criteria: "≥ 18 years old with a previous diagnosis of HFpEF. HFpEF was defined as current New York Heart Association (NYHA) functional class II or III HF symptoms or signs, left ventricular ejection fraction (LVEF) ≥ 50% according to echocardiography, diastolic dysfunction with elevated LV filling pressure according to Dopplerechocardiograph" "the subjects had to have a blood pressure of ≤ 150/95 mm Hg for 4 weeks before enrollment and the ability to walk ≥ 50 m at the time of enrollment. Treatment with an ACEI, or ARB if ACEI intolerant, was required for ≥ 4 weeks before enrollment. " Exclusion criteria: "Exclusion criteria included current treatment with spironolactone or epleronone, previous intolerance to spironolactone, creatinine > 2.5 mg/dL, serum potassium > 5.0mEq/L, significant valvular heart disease, pericardial disease, severe chronic lung disease with cor pulmonale, unstable angina or myocardial infarction ≤ 4 weeks before enrollment, severe peripheral vascular disease with claudication that limited walking distance, presence of other severe comorbid conditions with a life expectancy < 6 months, and pregnant or lactating women." Randomised (N): 48 (24 intervention, 24 control) Withdrawn (N): for reasons other than death (3 intervention (hyperkalaemia),0 control) Lost to follow‐up (N): not reported Analysed (N): not reported Age (years, mean, SEM): intervention: 66.3, 2.2; control: 76.4, 1.6 Sex (% men): 0 Ethnicity (%): not reported Systolic blood pressure (mmHg, mean, SEM): intervention: 137.0, 4.1; control: 133.1, 2.8 Heart rate (beats/min, mean, SEM): intervention: 64.2, 2.3; control: 61.1, 1.2 BMI (mean, SEM): intervention: 29.4, 2.2; control: 26.3, 1.2 Serum creatinine not reported B‐type natriuretic peptide (pg/mL): not reported NT pro B‐type natriuretic peptide (pg/mL): not reported LVEF (%, mean, SEM): intervention: 62.5, 1.2; control: 62.9, 1.2 NYHA class I (%): 0 NYHA class II (%): intervention: 33; control: 42 NYHA class III (%): intervention: 67; control: 58 NYHA class IV (%): 0 Hypertension (%): intervention: 87.5; control: 79.2 Diabetes (%): intervention: 50; control: 25 Atrial fibrillation (%): intervention: 25; control: 25 Hospitalisation for heart failure (%): intervention: 58.3; control: 54.2 Coronary heart disease (%): intervention: 37.5; control: 33.3 Stroke (%): not reported Diuretic (%): intervention: 83.3; control: 75 Digoxin (%): intervention: 12.5; control: 8.3 Beta‐blocker (%): intervention: 62.5; control: 62.5 ACEI (%): intervention: 70.8; control: 66.7 ARB (%): intervention: 29.2; control: 37.5 MRA (%): study drug |
|
| Interventions |
Intervention: Spironolactone, 25mg once daily Comparator: placebo Concomitant medication: not reported |
|
| Outcomes |
Planned: no known published protocol or pre‐enrolment clinical trial registry record Reported: 6 min walk distance, clinical composite score, doppler echocardiography, biomarkers, Kansas City Cardiomyopathy Questionnaire clinical summary score |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomly allocated", no further details |
| Allocation concealment (selection bias) | Low risk | "subjects were randomly allocated with the use of pharmacy‐controlled concealed randomization methods.", no further details |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | double‐blind, placebo controlled, no further details |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | not reported |
| Selective reporting (reporting bias) | Unclear risk | no able to assess due to lack of pre‐registration in clinical trial registry and published protocol |
| Other bias | High risk | clinical trial registry entry after start of enrolment, was originally marked as an observational study (2005‐2013) and changed to a randomised trial status in 2013. reported as a RCT in 2014 publication. funded by Women’s Fund; Houston, Texas |