N/A
Completed N=320
Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients
Source: ClinicalTrials.gov NCT02546856 ↗Enrolled (actual)
320
Serious AEs
4.5%
Results posted
Nov 2020
Primary outcomePrimary: BB % Relative Dose (Mean) With Regard to Target Dose — 56.29; 71.09 percentage of target dose — p=<0.001
Summary
Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless, dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety. Objective: To compare doses achieved by patients of BB, ACEI, ARB II and MRA in 4 months ( % relative to target doses) in the intervention group (HF nurse) and in the control group ( cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New ("de novo") HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17 Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. In the control group doses are decided by the cardiologist clinical support and education being provided by nurses. Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF), NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP), 6min. walking test, Creatinine/Glomerular Filtration Rate (GFR), Potassium (K), haemoglobin, Blood Pressure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be provided on the effectiveness of this healthcare management, that could be economically evaluated in future studies. A qualitative study also will be undertaken to explore barriers and facilitators to implementation
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BB % Relative Dose (Mean) With Regard to Target Dose |
56.29; 71.09 | <0.001 sig |
| SECONDARY Number of Participants With Worsening Renal Function (From Baseline to 4th Month) |
6; 4 | 0.52 |
| SECONDARY Number of Participants With Potassium (K) ≥5.5 Meq/l (From Baseline to 4 Month) |
3; 6 | 0.31 |
| SECONDARY Number of Participants With Symptomatic Hypotension (From Baseline to 4 Month) |
13; 12 | 0.85 |
| SECONDARY Number of Participants With Heart Rate (HR) < 50 Beats Per Minute (From Baseline to 4 Month) |
7; 10 | 0.44 |
| SECONDARY Number of Patients With Atrio Ventricular (AV) Block Due to Titration |
0; 0 | — |
| SECONDARY Number of Patients With Worsening of Heart Failure Signs and Symptoms |
1; 2 | 0.56 |
| SECONDARY Number of Patients With Admissions Due to Titration |
0; 0 | — |
| SECONDARY Number of Patients: Mortality Due to Titration |
0; 0 | — |
| SECONDARY Number of Paticipants With Drug Stop (Some Titration Drug Withdrawal Due to Intolerance, no Need or Change to Other Treatment) |
3; 1; 3; 0; 0; 1 | — |
| SECONDARY Change in % Left Ventricular Ejection Fraction |
15.46; 15.63 | 0.96 |
| SECONDARY N-terminal Pro-B Type Natriuretic Peptide Improvement (Nt-proBNP) |
-1577; -1593 | 0.97 |
| SECONDARY 6 Minute Walking Test |
50.49; 57.76 | 0.44 |
| SECONDARY Number of Participants n(%) in New York Heart Association Functional Classification I,II,III,IV |
47; 59; 86; 72; 4; 4 | — |
| SECONDARY Quality of Life: MLWHFQ |
-25.01; -26.37 | 0.75 |
| SECONDARY European Quality of Life Scale: EuroQol- 5 Dimension Index |
0.04; 0.08 | 0.20 |
| SECONDARY Number of Patients With Admissions Due to Heart Failure (HF) |
9; 1 | 0.01 sig |
| SECONDARY Number of Patients With Deaths |
2; 2; 2; 1 | 0.71 |
| SECONDARY ACEI % Relative Dose (Mean) With Regard to Target Dose |
56.13; 72.61 | <0.001 sig |
| SECONDARY ARB % Relative Dose (Mean) With Regard to Target Dose |
43.51; 44.48 | 0.93 |
| SECONDARY MRA % Relative Dose (Mean) With Regard to Target Dose |
70.47; 71.00 | 0.86 |
Eligibility Criteria
Inclusion Criteria
- Patient with "de novo" heart Failure and LVEF <= 40% admitted in hospital, without contraindications for BB prescription with cardiologist up-titration prescription and without having achieved BB target dose previous discharge and signing informed consent.
Exclusion Criteria
- Contraindications for BB.
- Living in a nursing home.
- Life expectancy < 6 months.
- Unable to self-care or mental disease without caregiver.
- Unable to weight
- Without phone
- Unable to go to clinic visit.
Data sourced from ClinicalTrials.gov (NCT02546856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.