Point Of Care With Serial NT-proBNP Measurement in Patients With Acute Decompensation of Heart Failure as a Therapy-monitoring During Hospitalization: A Prospective, Unblinded, Randomized, Controlled Pilot Trial - The POC-HF Trial

The proposed study is a prospective, unblinded, single center, 2-arm randomized controlled pilot trial. In the intervention arm serial measurement of NT-proBNP will be made available to the treating physician. A control group continuing to undergo care according to the 2016 ESC Guidelines will serve as comparator. Changes in NT-proBNP levels, safety laboratory parameters such as sodium, potassium, creatinine, Heart failure (HF) medication, vital signs, body weight and BMI, Quality of Life (QoL), length of hospital stay, New York Heart Association (NYHA) functional class, adverse events, transfer to the Intensive Care Unit and mortality will be recorded in patients with ADHF.

The Kantonsspital Baselland (KSBL) Liestal will be the only study center. All members of the study group will the thoroughly instructed regarding study procedures. Inclusion visits will be conducted only by a member of the study group. All Patients with ADHF on the medical ward of the KSBL Liestal will be provided an information sheet regarding goals and procedures of the study and the informed consent. Inclusion criteria will be checked after admission. Patients not matching the inclusion criteria at the screening visit cannot participate in this study. Patients will be provided sufficient time for their decision. The investigators communicate clearly that participation in the study is absolutely voluntary and refusal of participation has no influence on treatment during hospitalization.

In order to minimize bias that may be introduced by even minor differences in executing and interpreting technical exams, all study related measurements and procedures will be performed in a centralized manner at the KSBL Liestal.

Patients will be included only after approval of informed consent. Randomization is performed using 50 closed envelopes containing a paper shit with either the letter A or B. In total there are 25 A's and 25 B's. The letter A stands for the control group and the letter B for the intervention group. These envelopes are mixed initially, numbered for order purposes and the order maintained throughout the study. The name of the patient will be written down on the envelope. Then it will be open and the patient will be allocated to the study group depending on the letter in the envelope. All patients will undergo an inclusion and discharge visit. General demographic data, including age, gender, nationality, smoking status, alcohol consumption, current profession, exercise behavior, allergies, medication, HF history and comorbidities will be recorded. Assessment of vital signs and body weight will be performed together with an electrocardiogram, several laboratory tests (NT-proBNP, potassium, sodium and creatinine). In addition, questionnaires concerning QoL (SF-12, KCCQ, MLWHFQ) will be filled in by the participants. Women who can get pregnant (not yet in menopause and last menstrual period less than 12 months, not surgically sterilized, ovaries and/or uterus not removed) will have to undergo a pregnancy test prior to inclusion into the study.

Patients allocated to the intervention group (POC-available group) will undergo serial measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day. The investigators have chosen this time-lag because an earlier time point would not show the change of the security parameter creatinine due to longer half-life-time. For this test, blood is collected from the patients. These samplings will be done in the morning together with the regularly blood collection through the attending nurse according to the established procedure of the KSBL Liestal in the morning. 10ml blood will be collected for this study during each blood sample with a standard Lithium-blood-collection tube. Members of the study team will collect the blood samples and analyses them on the study devices. The result of the test will be provided directly to the responsible physician of the medical department at the KSBL Liestal. Treatment changes are at the discretion of the responsible physician. The physician will be alerted by a phone call of a study member if the NT-proBNP hasn't decreased by 10% or more between two measurements. But no specific recommendations with regards to therapy will be provided by the investigator or his team. However, diagnostic and therapeutic decisions will be based on the current 2016 ESC guidelines on the diagnosis and therapy of HF as established at the KSBL Liestal.