NCT01033591

Trial name or title	Exercise for Patients with Heart Failure in Primary Care: the EFICAR
Methods	RCT
Participants	Inclusion criteria: Age ≥ 18 years Diagnosis of HF on the basis of signs and symptoms (Framingham criteria) and evidence of structural heart alterations detected by echocardiography. Echocardiography scanning guarantees that we are dealing with participants with HF avoiding confounding clinical factors LVEF < 45% NYHA functional Class II‐IV, or Stages B and C of the American Heart Association, in a stable situation for at least the previous 4 weeks, with no changes in baseline functional status, no signs of congestion or changes in weight faster than 2 kg in 3 days Receiving optimal treatment with angiotensin‐converting enzyme inhibitors, angiotensin II receptor antagonists, beta‐blockers, diuretics and aldosterone antagonists at stable doses for the previous 4 weeks, as long as there are no justified contraindications for their use, and meeting the clinical practice guidelines of the European Society of Cardiology 600 participant target
Interventions	Experimental: exercise supervised exercise + optimised treatment according to the European Society of Cardiology guidelines No intervention: control optimised treatment according to the European Society of Cardiology guidelines
Outcomes	Primary outcomes: Change in HRQoL (SF‐36 and Minnesota Living with Heart Failure Questionnaire) Secondary outcomes: Change in functional capacity (6‐min walking test) Cardiac structural changes (B‐type natriuretic peptide) Muscle strength (dynamometer) Body composition (fat and muscular weight) All at 12 months
Starting date	January 2011
Contact information	Contact: Dr Gonzalo Grandes
Notes	Zuazagoitia A, Grandes G, Torcal J, Lekuona I, Echevarria P, Gómez MA, Domingo M, de la Torre MM, Ramírez JI, Montoya I, Oyanguren J, Pinilla RO; EFICAR Group (Ejercicio Físico en la Insuficiencia Cardiaca). Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with HF in primary care: The EFICAR study protocol. BMC Public Health. 2010;10:33 Trial still recruiting. Recruitment completion expected June 2014 (author email reply 20 July 2013)

HF: heart failure; HRQoL: health‐related quality of life; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; min: minute; RCT: randomised controlled trial; SF‐36: 36‐item Short Form; VCO₂: carbon dioxide consumption; VE: ventilatory efficiency; VO₂: oxygen consumption.