Ref (type) | Population | Outcome, Interventions | Results and statistical analysis | Effect size | Favours |
Headache | |||||
[78]
RCT 3-armed trial |
642 men aged 18 to 75 years with stable chronic congestive heart failure (all participants were already receiving diuretics and digoxin) |
Proportion of people with headache
23/186 (12%) with hydralazine plus isosorbide dinitrate 1/273 (0.4%) with placebo |
Significance not assessed |
||
[79]
RCT |
1050 African-Americans with New York Heart Association (NYHA) class III or IV heart failure with dilated ventricles |
Proportion of people with headache
6 months
48% with hydralazine plus isosorbide dinitrate 19% with placebo Absolute numbers not reported |
P <0.001 The RCT was terminated early (after 10 months instead of 18 months) because mortality was higher with placebo |
Effect size not calculated | placebo |
Dizziness | |||||
[78]
RCT 3-armed trial |
642 men aged 18 to 75 years with stable chronic congestive heart failure (all participants were already receiving diuretics and digoxin) |
Proportion of people with dizziness
12/186 (6%) with hydralazine plus isosorbide dinitrate 5/273 (2%) with placebo |
Significance not assessed |
||
[79]
RCT |
1050 African-Americans with NYHA class III or IV heart failure with dilated ventricles |
Proportion of people with dizziness
6 months
29% with hydralazine plus isosorbide dinitrate 12% with placebo Absolute numbers not reported |
P <0.001 The RCT was terminated early (after 10 months instead of 18 months) because mortality was higher with placebo |
Effect size not calculated | placebo |