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. 2016 Jul 8;2016(7):CD009077. doi: 10.1002/14651858.CD009077.pub3

Diniz 2004.

Methods

  1. Design: parallel (2 arms)

  2. Country: Brazil

  3. Multicenter:

  4. International: no

  5. Intention‐to‐treat for mortality from any cause: yes.

  6. Follow‐up period: 6 months
Participants

  • Enrolled: 63

  • Randomized: 30

  1. Carvedilol group: 15

  2. Placebo group:  15

  •  Participants receiving drug: 30

  1. Carvedilol group: 15

  2. Placebo group: 15

  •  Lost post‐randomisation: 10% (3/30)

  1. Carvedilol group: 6.6% (1/15)

  2. Placebo group: 13.2% (2/15)

  3. Imbalance between comparison groups: 6.6%

  • Analysed:

  1. Carvedilol group: 80% (12/15)

  2. Placebo group: 86.6% (13/15)

  3. Differences between comparison groups: 6.6%

  • Age (years, mean (SD)):

  1. Carvedilol group: 46.2 (7.62)

  2. Placebo group: 51.06 (6.11)

  • Follow up (weeks, mean (SD)):

  1. Carvedilol group: 28.78 (1.48)

  2. Placebo group: 29.5 (1.79)

  • Gender (male):

  1. Carvedilol group: 83.3% (12/15)

  2. Placebo group: 73.3% (11/15)

  • Inclusion criteria:

  1. Age 18 to 65 years;

  2. New York Heart Association: II to IV;

  3. Ejection fraction and left ventricular fraction using isotopic ventriculography: ≤ 35%;

  4. All of the participants were already using digitalis, diuretics, angiotensin converting enzyme inhibitors and spironolactone, and may or may not have been using amiodarone and anticoagulant.

  •  Exclusion criteria:

  1. Functional class IV requiring use of vasoactive drugs;

  2. Severe bradycardia ≤ 50 beats per minute;

  3. Atrioventricular blocks 2nd or 3rd degree, without permanent pacemaker;

  4. Systolic blood pressure ≤ 60 mm Hg;

  5. Comorbidities, such as renal insufficiency (creatinine ≥ 3.0), or hepatic disease, serious bronchial asthma, or chronic obstructive pulmonary disease;

  6. Pregnant or not using contraception.
Interventions

  1. Carvedilol group: 3.125 mg/day and up‐titrated every 8 days to 50 mg/day. Duration: 4 months

  2. Placebo: details not stated

  3. Nature of placebo: not stated
Outcomes

  • Outcomes were not explicitly described as primary or secondary:

  1. Functional class;

  2. Overall survival;

  3. Quality of life (Minnesota Living with Heart Failure questionnaire (MLHFQ));

  4. Blood pressure;

  5. Heart rate;

  6. Electrocardiogram parameters;

  7. Ventricular remodeling;

  8. Change in left ventricular ejection fraction;

  9. Change in noradrenaline and brain natriuretic peptide levels;

  10. Adverse events.
Notes

  1. Clinical trial number: not applicable

  2. Sample size estimation a priori: not given

  3. Trial conduction date: not given

  4. Sponsor: not stated

  5. Conflict of interest: not stated

  6. Data were gathered from PhD thesis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement of 'low risk' or 'high risk'
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement of 'low risk' or 'high risk'
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement of 'low risk' or 'high risk'
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss post‐randomisation: 16.6%.
 Comment: this trial had a small sample size; therefore, 16.6% could be considered a high loss of participants.
Selective reporting (reporting bias) Low risk This trial included four important outcomes: mortality, adverse events, quality of life, and safety.
Other bias Low risk ‐

SD = standard deviation

≥ = greater than or equal to

≤ = less than or equal to