Point Of Care With Serial NT-proBNP Measurement in Patients With Acute Decompensation of Heart Failure

NCT04471610 | Completed

• 1 other identifier: 2017-01030
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to explore whether the availability of serial NT-proBNP measurements together with safety parameters such as electrolytes and creatinine may influence treatment decision in patients with acute decompensated heart failure (ADHF) leading to more rapid and faster dose increase of prognostic therapies and earlier hospital discharge.

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (2)

• Changes in NT-proBNP

  Meassurement of NT-proBNP

  Up to 4 weeks, on average 10 days

• Dosage and variations in medication to treat heart failure

  Changes in medical heart failure therapies such as Diuretics, Nitrates, Angiotensin-converting-enzyme (ACE) Inhibitors or angiotensin-receptor blockers (ARBs), Beta blocker

  Up to 4 weeks, on average 10 days

Secondary Outcomes (12)

• HR (in beats/min)

  Up to 4 weeks, on average 10 days

• BP (in mmHg)

  Through study completion, on average 10 days

• BMI and Body weight

  Up to 4 weeks, on average 10 days

• KCCQ (Kansas City Cardiomyopathy ) Questionnaire

  Up to 4 weeks, on average 10 days

• SF12 (Short Form 12 Health Survey ) Questionnaire

  Up to 4 weeks, on average 10 days

Study Arms (2)

Control group

NO INTERVENTION

Group A: Patients allocated to the control group will undergo the measurements at inclusion and discharge visit. The control group conduces to compare the NT-proBNP and HF medication changes under therapy monitoring with serial NT-proBNP measurements to the NT-proBNP and HF medication changes with sign and symptom guided HF therapy. The diagnostic and therapeutic decisions in the control Group and in the Intervention group will be based on the current 2016 ESC guidelines on the diagnosis and therapy of HF as established at the KSBL Liestal. At discharge, the same measurements as at the inclusion visit will be repeated in all patients to monitor the effects associated with the participation in this trial.

POC-available group

EXPERIMENTAL

Group B: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 blood collection (10 ml of Lithium Heparin blood) for these tests will be done in the morning together with the regularly blood collection. The study team does the the analysis on the study devices. The result of the test will be provided directly to the responsible physician. 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.

Other: Serial measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day

Interventions

Serial measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day OTHER

Serial measurements of NT-proBNP, sodium, potassium, and creatinine in the NT-proBNP-group vs. no serial measurements in control group. In the intervention group the body weight, vital parameters, therapy changes and adverse events are documented the above mention serial measurement every second business day.

POC-available group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• NYHA functional class II or III
• Symptoms of heart failure:
• E.g.: Dyspnea Paroxysmal nocturnal dyspnea Reduced exercise capacity Fatigue Extended recovery after exercising Peripheral edema (lower leg, ankle) NT-proBNP \>300 (pg/ml)
• Age \> 18 Years

You may not qualify if:

• NYHA functional class I or IV
• NT-proBNP \< 1200 pg/ml and creatinine clearance \< 60 ml/min (Clearance (ml/min) = 1.23(women 1.03) x body weight (Kg) x (140-Age)/ creatinine (umol/L)) Creatinine clearence: \_\_\_\_\_\_\_\_\_\_\_ \<60ml/min
• Heart failure due to chemotherapeutic drugs
• Uncontrolled brady- or tachyarrythmia
• Unstable angina pectoris
• Severe uncorrected valvular disease
• Planned cardiac intervention in the next 6 months
• Clinically significant concomitant disease states:
• On-going cancer treatment
• Active infection
• Immunosuppressive medical therapy
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the study procedures (Due to language problems, psychological disorders, dementia, etc.)
• Participation in another intervention study
• Enrolment of investigators or their family members

Sponsors & Collaborators

• Prof. Dr. Jörg Leuppi: lead

Study Sites (1)

Cantonal Hospital Baselland Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

Location

MeSH Terms

Interventions

Potassium; Sodium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Jörg D. Leuppi, Prof.

  Head of Medical University Clinic, Cantonal hospital Baselland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Internal Medicine

Model Details: 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, HF medication, vital signs, body weight and BMI, QoL, length of hospital stay, NYHA functional class, adverse events, transfer to the Intensive Care Unit and mortality will be recorded in patients with ADHF.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 15, 2020
• Study Start: January 23, 2018
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

CH (1)