Clinical trial NCT02939157: Pocket-sized Ultrasound for Point-of-care Diagnosis of Heart Failure
Official title: Pocket-sized Ultrasound for Point-of-care Diagnosis of Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Cardiac Failure
Keywords: Diagnostic Ultrasound
Primary Care
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 158
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 250 adult study patients consulting to GPs in primary care for suspected cardiac failure.

Brief summary: Assessment of pocket sized ultrasound (Vscan GE Healthcare) for diagnosing heart failure in primary care patients, with a comprehensive cardiac ultrasound examination (Siemens Acusan P10) performed at a specialized the eco.lab, as reference.

Detailed description: Waiting times for cardiac ultrasound is a cause of delay in identification of heart failure, which means delayed treatment, or that treatment recommendations are based on insufficient knowledge. Heart failure is a common condition; about 10% of 80-year-old people are affected and most patients are treated within primary care. A new ultrasound technology with integrated software support for interpretation (pocket-sized ultrasound) promises to improve care for heart patients and lead to earlier treatment with effective drugs. In cooperation with Norwegian researchers and the Region of Jämtland Härjedalen, this project opens opportunities for a significant medical innovation. The new concept, pocket-sized ultrasound for diagnosis of heart failure, has not previously been validated in patients seen in primary care. A new study may provide very important information that is directly applicable in the care of heart failure patients. We aim to recruit 250 study patients from the waiting list of patients referred from GPs, to ultrasound at the dpt. Of Clinical Physiology, Östersund Hospital, due to a suspicion of heart failure. The examinations will be carried out during the same day, with the investigators blinded to each other. The new concept of ultrasound has a potential to provide more cost-effective identification and monitoring of patients with heart failure in primary care.

Eligibility criteria: Inclusion Criteria: Study patients fulfil all of the following criteria:

1. Age 20 and over
2. Recruited from primary care clinics, in the Region of Jämtland Härjedalen, Sweden.
3. Referred to comprehensive cardiac ultrasound (reference method) from GPs, due to suspected heart failure.
4. Provide written informed consent before enrolment.

Exclusion Criteria:

1. Non consenting patients.
2. Patients in need of acute medical attention.

Primary outcomes:
measure: Cardiac failure
timeFrame: Assessment of cardiac failure by the study method (pocket sized ultrasound) is made on the same day as the reference method (comprehensive cardiac ultrasound), by independent investigators.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Umeå University
name: Gunnar Nilsson, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson G, Soderstrom L, Alverlind K, Samuelsson E, Mooe T. Hand-held cardiac ultrasound examinations performed in primary care patients by nonexperts to identify reduced ejection fraction. BMC Med Educ. 2019 Jul 25;19(1):282. doi: 10.1186/s12909-019-1713-9.