Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients
Phase: NA
Conditions: Heart Failure
Sponsor: Hospital Galdakao-Usansolo

    Study identification 
 
     
    Official Title: Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF)                               
                            Patients.  
 
 
ClinicalTrials.gov Identifier: NCT02546856. 
 
 
Document Date: March 1, 2015  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study protocol 
 
The protocol of the 2 randomised groups, is briefly summarized: 
 
HF-cardiologist group (control): Usual care provided at a HF Unit was planned. A HF-cardiologist was responsible 
 
for prescription and titration, also based on European Society of Cardiology guidelines and addenda1,2 and control 
nurse for clinical evaluation and self-care education, similar to the HF-nurse group with the exception of the titration 
process. The number of visits depended on each hospital’s organization. 
  
 
 
 
 
 
 
HF-nurse group (intervention): The protocol was based on the European Heart Failure (HF) Guidelines.1,2 HF-nurse 
requirements were 400-hour HF training and at least 2 years of experience. HF-nurses worked in a team with a HF-
cardiologist. Initial drug prescription and expected rate of titration was made by the cardiologist, while the titration process 
planning was made by HF-nurse. Weekly or biweekly face to face visits were planned, and biweekly drug up-titration, 
alternating different drugs, was considered. Clinical and analytical evaluation and patient education prior to each increase 
were required. Dose adjustment of just one drug at each visit, safety checklist review and routine supervision by cardiologist 
were established. The titration process was tailored to each individual. Cardiologist availability for consultation or visit and 
early care for decompensation were also established. (See Tables) 
 
1.McMurray JJV, Adamopoulos S, Anker SD et al. ESC Guidelines for the diagnosis and treatment of acute and 
chronic heart failure 2012 Eur Heart J 2012; 33:1787–1847. 
 
2. McMurray JJ, Adamopoulos S, Anker SD,Auricchio A, BöhmM, Dickstein K, Falk V,Filippatos G, Fonseca C, 
Gomez SanchezMA, Jaarsma T, Køber L, Lip GYH,Maggioni AP, Parkhomenko A, PieskeBM, Popescu BA, 
Rønnevik PK, RuttenFH, Schwitter J, Seferovic P, Stepinska J,Trindade PT, Voors AA, Zannad F, ZeiherA. ESC 
guidelines for the diagnosis andtreatment of acute and chronic heartfailure 2012: Addenda. Eur Heart J [online] 
2012  1-8.  www.escardio.org/guidelines-surveys/es-guidelines/GuidelinesDocuments/Guidelines-Heart-Failure 
 
web-tables.pdf (15 May 2013). 

ClinicalTrials.gov Identifier: NCT02546856. ETIFIC multicentre randomized trial protocol. J. Oyanguren et al. 
 

ClinicalTrials.gov Identifier: NCT02546856. ETIFIC multicentre randomized trial protocol. J. Oyanguren et al. 
 

 
ClinicalTrials.gov Identifier: NCT02546856. ETIFIC multicentre randomized trial protocol. J. Oyanguren et al. 
 

 
 
 
ClinicalTrials.gov Identifier: NCT02546856. ETIFIC multicentre randomized trial protocol. J. Oyanguren et al.