Changes in clinical variables and laboratory tests at 1 month and final visit for participants randomized to spironolactone or control
| Clinical variables . | ||||||||
|---|---|---|---|---|---|---|---|---|
| . | One month . | . | End of trial . | . | ||||
| . | Control . | Spironolactone . | Difference . | P . | Control . | Spironolactone . | Difference . | P . |
| N | 257 | 259 | 255 | 251 | ||||
| Days follow-up | 31 (28 to 35) | 32 (28 to 35) | 267 (184 to 275) | 266 (176 to 274) | ||||
| NYHA >1 | N = 33 | N = 40 | +7 | 0.669 | N=35 | N=35 | 0 | 0.765 |
| Loop diuretic | N = 2 | N = 1 | −1 | 0.558 | N=7 | N=2 | −5 | 0.097 |
| Mean (SD) change | Mean difference (95% CI) | Mean (SD) change | Mean difference (95% CI) | |||||
| Breathlessness | −0.1 (2.1) | −0.1 (2.3) | +0.1 (−0.4 to +0.4) | 0.884 | 0.0 (2.2) | +0.1 (2.4) | +0.1 (−0.3 to +0.4) | 0.731 |
| Ankle Swelling | −0.1 (1.6) | −0.1 (1.6) | +0.1 (−0.2 to +0.4) | 0.547 | −0.2 (1.8) | 0.0 (2.0) | +0.3 (0.0 to +0.6) | 0.061 |
| EQ5D VAS | +2 (14) | +1 (15) | −2 (−4 to 0) | 0.077 | 0 (15) | −1 (16) | −1 (−3 to +1) | 0.380 |
| Shuttles Completed | +0.5 (8.7) | +1.5 (9.5) | +1.0 (−0.9 to +2.8) | 0.322 | +1.6 (17.2) | +3.7 (20) | +1.6 (−1.7 to +5.0) | 0.342 |
| Physical signs | ||||||||
| Weight (kg) | 0.1 (1.5) | −0.5 (1.2) | −0.5 (−0.8 to −0.3) | <0.001 | −0.5 (2.8) | −0.9 (2.5) | −0.3 (−0.8 to 0.2) | 0.178 |
| Heart Rate (bpm) | 0 (8) | 0 (7) | 0 (−1 to +2) | 0.490 | 0 (8) | −1 (7) | −1 (−2 to +1) | 0.329 |
| Sys BP (mmHg) | −3 (16) | −9 (16) | −6 (−9 to −3) | <0.001 | −3 (19) | −13 (18) | −10 (−13 to −7) | <0.001 |
| Dia BP (mmHg) | 0 (11) | −3 (8) | −2 (−4 to +1) | 0.003 | −1 (10) | −4 (9) | −3 (−5 to −2) | <0.001 |
Post-exercise Sys. BP (mmHg) | −3 (25) | −11 (26) | −8 (−14 to −3) | 0.001 | −5 (27) | −16 (27) | −11 (−16 to −7) | <0.001 |
| Laboratory tests | ||||||||
| Haemoglobin (g/dL) | −0.2 (0.6) | −0.1 (0.6) | +0.1 (0 to +0.2) | 0.110 | −0.3 (0.8) | −0.4 (0.9) | −0.1 (−0.3 to 0.0) | 0.089 |
| Sodium (mmol/L) | +0.2 (2.1) | −1.0 (2.4) | −1.2 (−1.5 to −0.8) | <0.001 | 0.0 (2.4) | −1.1 (2.5) | −1.2 (−1.6 to −0.8) | <0.001 |
| Potassium (mmol/L) | 0.0 (0.3) | +0.2 (0.4) | +0.2 (+0.2 to +0.3) | <0.001 | 0.0 (0.4) | +0.2 (0.4) | +0.2 (+0.2. +0.3) | <0.001 |
| >5.5 mmol/L | N = 1 | N = 7 | 0.110 | N= 1 | N = 4 | 0.079 | ||
| Urea (mmol/L) | +0.4 (2.8) | +1.4 (3.2) | +1.0 (+0.5 to +1.6) | <0.001 | +0.5 (3.4) | +1.8 (4.1) | +1.3 (+0.7 to +2.0) | <0.001 |
| Creatinine (µmol/L) | +1 (9) | +5 (10) | +4 (+3 to +6) | <0.001 | +4 (17) | +9 (13) | +5 (+2 to +8) | <0.001 |
| eGFR mL/min/1.73m2 | −1 (8) | −4 (8) | −3 (−5 to −2) | <0.001 | −2 (9) | −7 (10) | −5 (−6 to −3) | <0.001 |
Number <45 mL/min/1.73m2 | N = 13 | N = 25 | 0.143 | N = 20 | N =32 | 0.032 | ||
| Clinical variables . | ||||||||
|---|---|---|---|---|---|---|---|---|
| . | One month . | . | End of trial . | . | ||||
| . | Control . | Spironolactone . | Difference . | P . | Control . | Spironolactone . | Difference . | P . |
| N | 257 | 259 | 255 | 251 | ||||
| Days follow-up | 31 (28 to 35) | 32 (28 to 35) | 267 (184 to 275) | 266 (176 to 274) | ||||
| NYHA >1 | N = 33 | N = 40 | +7 | 0.669 | N=35 | N=35 | 0 | 0.765 |
| Loop diuretic | N = 2 | N = 1 | −1 | 0.558 | N=7 | N=2 | −5 | 0.097 |
| Mean (SD) change | Mean difference (95% CI) | Mean (SD) change | Mean difference (95% CI) | |||||
| Breathlessness | −0.1 (2.1) | −0.1 (2.3) | +0.1 (−0.4 to +0.4) | 0.884 | 0.0 (2.2) | +0.1 (2.4) | +0.1 (−0.3 to +0.4) | 0.731 |
| Ankle Swelling | −0.1 (1.6) | −0.1 (1.6) | +0.1 (−0.2 to +0.4) | 0.547 | −0.2 (1.8) | 0.0 (2.0) | +0.3 (0.0 to +0.6) | 0.061 |
| EQ5D VAS | +2 (14) | +1 (15) | −2 (−4 to 0) | 0.077 | 0 (15) | −1 (16) | −1 (−3 to +1) | 0.380 |
| Shuttles Completed | +0.5 (8.7) | +1.5 (9.5) | +1.0 (−0.9 to +2.8) | 0.322 | +1.6 (17.2) | +3.7 (20) | +1.6 (−1.7 to +5.0) | 0.342 |
| Physical signs | ||||||||
| Weight (kg) | 0.1 (1.5) | −0.5 (1.2) | −0.5 (−0.8 to −0.3) | <0.001 | −0.5 (2.8) | −0.9 (2.5) | −0.3 (−0.8 to 0.2) | 0.178 |
| Heart Rate (bpm) | 0 (8) | 0 (7) | 0 (−1 to +2) | 0.490 | 0 (8) | −1 (7) | −1 (−2 to +1) | 0.329 |
| Sys BP (mmHg) | −3 (16) | −9 (16) | −6 (−9 to −3) | <0.001 | −3 (19) | −13 (18) | −10 (−13 to −7) | <0.001 |
| Dia BP (mmHg) | 0 (11) | −3 (8) | −2 (−4 to +1) | 0.003 | −1 (10) | −4 (9) | −3 (−5 to −2) | <0.001 |
Post-exercise Sys. BP (mmHg) | −3 (25) | −11 (26) | −8 (−14 to −3) | 0.001 | −5 (27) | −16 (27) | −11 (−16 to −7) | <0.001 |
| Laboratory tests | ||||||||
| Haemoglobin (g/dL) | −0.2 (0.6) | −0.1 (0.6) | +0.1 (0 to +0.2) | 0.110 | −0.3 (0.8) | −0.4 (0.9) | −0.1 (−0.3 to 0.0) | 0.089 |
| Sodium (mmol/L) | +0.2 (2.1) | −1.0 (2.4) | −1.2 (−1.5 to −0.8) | <0.001 | 0.0 (2.4) | −1.1 (2.5) | −1.2 (−1.6 to −0.8) | <0.001 |
| Potassium (mmol/L) | 0.0 (0.3) | +0.2 (0.4) | +0.2 (+0.2 to +0.3) | <0.001 | 0.0 (0.4) | +0.2 (0.4) | +0.2 (+0.2. +0.3) | <0.001 |
| >5.5 mmol/L | N = 1 | N = 7 | 0.110 | N= 1 | N = 4 | 0.079 | ||
| Urea (mmol/L) | +0.4 (2.8) | +1.4 (3.2) | +1.0 (+0.5 to +1.6) | <0.001 | +0.5 (3.4) | +1.8 (4.1) | +1.3 (+0.7 to +2.0) | <0.001 |
| Creatinine (µmol/L) | +1 (9) | +5 (10) | +4 (+3 to +6) | <0.001 | +4 (17) | +9 (13) | +5 (+2 to +8) | <0.001 |
| eGFR mL/min/1.73m2 | −1 (8) | −4 (8) | −3 (−5 to −2) | <0.001 | −2 (9) | −7 (10) | −5 (−6 to −3) | <0.001 |
Number <45 mL/min/1.73m2 | N = 13 | N = 25 | 0.143 | N = 20 | N =32 | 0.032 | ||
Dia BP, diastolic blood pressure; eGFR, estimated glomerular filtration rate by the four-variable modified diet in renal disease (MDRD) equation; NYHA, New York Heart Association Class; Sys BP, systolic blood pressure; VAS, visual analogue score.
Values shown in bold are significant at a P-value <0.05
Changes in clinical variables and laboratory tests at 1 month and final visit for participants randomized to spironolactone or control
| Clinical variables . | ||||||||
|---|---|---|---|---|---|---|---|---|
| . | One month . | . | End of trial . | . | ||||
| . | Control . | Spironolactone . | Difference . | P . | Control . | Spironolactone . | Difference . | P . |
| N | 257 | 259 | 255 | 251 | ||||
| Days follow-up | 31 (28 to 35) | 32 (28 to 35) | 267 (184 to 275) | 266 (176 to 274) | ||||
| NYHA >1 | N = 33 | N = 40 | +7 | 0.669 | N=35 | N=35 | 0 | 0.765 |
| Loop diuretic | N = 2 | N = 1 | −1 | 0.558 | N=7 | N=2 | −5 | 0.097 |
| Mean (SD) change | Mean difference (95% CI) | Mean (SD) change | Mean difference (95% CI) | |||||
| Breathlessness | −0.1 (2.1) | −0.1 (2.3) | +0.1 (−0.4 to +0.4) | 0.884 | 0.0 (2.2) | +0.1 (2.4) | +0.1 (−0.3 to +0.4) | 0.731 |
| Ankle Swelling | −0.1 (1.6) | −0.1 (1.6) | +0.1 (−0.2 to +0.4) | 0.547 | −0.2 (1.8) | 0.0 (2.0) | +0.3 (0.0 to +0.6) | 0.061 |
| EQ5D VAS | +2 (14) | +1 (15) | −2 (−4 to 0) | 0.077 | 0 (15) | −1 (16) | −1 (−3 to +1) | 0.380 |
| Shuttles Completed | +0.5 (8.7) | +1.5 (9.5) | +1.0 (−0.9 to +2.8) | 0.322 | +1.6 (17.2) | +3.7 (20) | +1.6 (−1.7 to +5.0) | 0.342 |
| Physical signs | ||||||||
| Weight (kg) | 0.1 (1.5) | −0.5 (1.2) | −0.5 (−0.8 to −0.3) | <0.001 | −0.5 (2.8) | −0.9 (2.5) | −0.3 (−0.8 to 0.2) | 0.178 |
| Heart Rate (bpm) | 0 (8) | 0 (7) | 0 (−1 to +2) | 0.490 | 0 (8) | −1 (7) | −1 (−2 to +1) | 0.329 |
| Sys BP (mmHg) | −3 (16) | −9 (16) | −6 (−9 to −3) | <0.001 | −3 (19) | −13 (18) | −10 (−13 to −7) | <0.001 |
| Dia BP (mmHg) | 0 (11) | −3 (8) | −2 (−4 to +1) | 0.003 | −1 (10) | −4 (9) | −3 (−5 to −2) | <0.001 |
Post-exercise Sys. BP (mmHg) | −3 (25) | −11 (26) | −8 (−14 to −3) | 0.001 | −5 (27) | −16 (27) | −11 (−16 to −7) | <0.001 |
| Laboratory tests | ||||||||
| Haemoglobin (g/dL) | −0.2 (0.6) | −0.1 (0.6) | +0.1 (0 to +0.2) | 0.110 | −0.3 (0.8) | −0.4 (0.9) | −0.1 (−0.3 to 0.0) | 0.089 |
| Sodium (mmol/L) | +0.2 (2.1) | −1.0 (2.4) | −1.2 (−1.5 to −0.8) | <0.001 | 0.0 (2.4) | −1.1 (2.5) | −1.2 (−1.6 to −0.8) | <0.001 |
| Potassium (mmol/L) | 0.0 (0.3) | +0.2 (0.4) | +0.2 (+0.2 to +0.3) | <0.001 | 0.0 (0.4) | +0.2 (0.4) | +0.2 (+0.2. +0.3) | <0.001 |
| >5.5 mmol/L | N = 1 | N = 7 | 0.110 | N= 1 | N = 4 | 0.079 | ||
| Urea (mmol/L) | +0.4 (2.8) | +1.4 (3.2) | +1.0 (+0.5 to +1.6) | <0.001 | +0.5 (3.4) | +1.8 (4.1) | +1.3 (+0.7 to +2.0) | <0.001 |
| Creatinine (µmol/L) | +1 (9) | +5 (10) | +4 (+3 to +6) | <0.001 | +4 (17) | +9 (13) | +5 (+2 to +8) | <0.001 |
| eGFR mL/min/1.73m2 | −1 (8) | −4 (8) | −3 (−5 to −2) | <0.001 | −2 (9) | −7 (10) | −5 (−6 to −3) | <0.001 |
Number <45 mL/min/1.73m2 | N = 13 | N = 25 | 0.143 | N = 20 | N =32 | 0.032 | ||
| Clinical variables . | ||||||||
|---|---|---|---|---|---|---|---|---|
| . | One month . | . | End of trial . | . | ||||
| . | Control . | Spironolactone . | Difference . | P . | Control . | Spironolactone . | Difference . | P . |
| N | 257 | 259 | 255 | 251 | ||||
| Days follow-up | 31 (28 to 35) | 32 (28 to 35) | 267 (184 to 275) | 266 (176 to 274) | ||||
| NYHA >1 | N = 33 | N = 40 | +7 | 0.669 | N=35 | N=35 | 0 | 0.765 |
| Loop diuretic | N = 2 | N = 1 | −1 | 0.558 | N=7 | N=2 | −5 | 0.097 |
| Mean (SD) change | Mean difference (95% CI) | Mean (SD) change | Mean difference (95% CI) | |||||
| Breathlessness | −0.1 (2.1) | −0.1 (2.3) | +0.1 (−0.4 to +0.4) | 0.884 | 0.0 (2.2) | +0.1 (2.4) | +0.1 (−0.3 to +0.4) | 0.731 |
| Ankle Swelling | −0.1 (1.6) | −0.1 (1.6) | +0.1 (−0.2 to +0.4) | 0.547 | −0.2 (1.8) | 0.0 (2.0) | +0.3 (0.0 to +0.6) | 0.061 |
| EQ5D VAS | +2 (14) | +1 (15) | −2 (−4 to 0) | 0.077 | 0 (15) | −1 (16) | −1 (−3 to +1) | 0.380 |
| Shuttles Completed | +0.5 (8.7) | +1.5 (9.5) | +1.0 (−0.9 to +2.8) | 0.322 | +1.6 (17.2) | +3.7 (20) | +1.6 (−1.7 to +5.0) | 0.342 |
| Physical signs | ||||||||
| Weight (kg) | 0.1 (1.5) | −0.5 (1.2) | −0.5 (−0.8 to −0.3) | <0.001 | −0.5 (2.8) | −0.9 (2.5) | −0.3 (−0.8 to 0.2) | 0.178 |
| Heart Rate (bpm) | 0 (8) | 0 (7) | 0 (−1 to +2) | 0.490 | 0 (8) | −1 (7) | −1 (−2 to +1) | 0.329 |
| Sys BP (mmHg) | −3 (16) | −9 (16) | −6 (−9 to −3) | <0.001 | −3 (19) | −13 (18) | −10 (−13 to −7) | <0.001 |
| Dia BP (mmHg) | 0 (11) | −3 (8) | −2 (−4 to +1) | 0.003 | −1 (10) | −4 (9) | −3 (−5 to −2) | <0.001 |
Post-exercise Sys. BP (mmHg) | −3 (25) | −11 (26) | −8 (−14 to −3) | 0.001 | −5 (27) | −16 (27) | −11 (−16 to −7) | <0.001 |
| Laboratory tests | ||||||||
| Haemoglobin (g/dL) | −0.2 (0.6) | −0.1 (0.6) | +0.1 (0 to +0.2) | 0.110 | −0.3 (0.8) | −0.4 (0.9) | −0.1 (−0.3 to 0.0) | 0.089 |
| Sodium (mmol/L) | +0.2 (2.1) | −1.0 (2.4) | −1.2 (−1.5 to −0.8) | <0.001 | 0.0 (2.4) | −1.1 (2.5) | −1.2 (−1.6 to −0.8) | <0.001 |
| Potassium (mmol/L) | 0.0 (0.3) | +0.2 (0.4) | +0.2 (+0.2 to +0.3) | <0.001 | 0.0 (0.4) | +0.2 (0.4) | +0.2 (+0.2. +0.3) | <0.001 |
| >5.5 mmol/L | N = 1 | N = 7 | 0.110 | N= 1 | N = 4 | 0.079 | ||
| Urea (mmol/L) | +0.4 (2.8) | +1.4 (3.2) | +1.0 (+0.5 to +1.6) | <0.001 | +0.5 (3.4) | +1.8 (4.1) | +1.3 (+0.7 to +2.0) | <0.001 |
| Creatinine (µmol/L) | +1 (9) | +5 (10) | +4 (+3 to +6) | <0.001 | +4 (17) | +9 (13) | +5 (+2 to +8) | <0.001 |
| eGFR mL/min/1.73m2 | −1 (8) | −4 (8) | −3 (−5 to −2) | <0.001 | −2 (9) | −7 (10) | −5 (−6 to −3) | <0.001 |
Number <45 mL/min/1.73m2 | N = 13 | N = 25 | 0.143 | N = 20 | N =32 | 0.032 | ||
Dia BP, diastolic blood pressure; eGFR, estimated glomerular filtration rate by the four-variable modified diet in renal disease (MDRD) equation; NYHA, New York Heart Association Class; Sys BP, systolic blood pressure; VAS, visual analogue score.
Values shown in bold are significant at a P-value <0.05
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