A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02807857
• Date of registration: 17/06/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care PREFER
• Scientific title: A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
• Date of first enrolment: July 7, 2016
• Target sample size: 4000
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02807857
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium, Croatia, Cyprus, Denmark, Estonia, France, Hungary, Israel, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Russian Federation, Slovenia, Spain

Contacts

• Name: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Willing and able to provide written informed consent and accept study procedures and
time schedule.

- Age = 18 years.

- Patients suffering from chronic heart failure (the heart failure diagnosis must have
been made or confirmed by a cardiologist and/or hospital physician at any time in the
patient's medical history).

- Patients with reduced ejection fraction (= 40%) as confirmed at any time point in the
patient's medical history.

Exclusion Criteria:

- Use of investigational drugs either within 5 half-lives of enrollment, or within 30
days, or until the expected pharmacodynamic effect has returned to baseline, whichever
is longer.

- Major surgery in the last 3 months prior to baseline or planned major surgery or
cardiac intervention during the study.

- Cancer or other significant co-morbidities implying that the patient's condition is
unstable.

- Comorbidities that can be associated with elevated natriuretic peptide (NP) levels:
renal insufficiency, (eGFR < 25 ml/min/1.73 m² calculated according to MDRD formula),
recent (less than 3 months) cerebral trauma or recent (less than 3 months)
cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the
last 3 months.

- Patients who are primarily managed and regularly followed-up by a cardiologist for
their HF

- Highly frail patients whose estimated lifespan due to comorbidities by the judgement
of the investigator is less than 6 months.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Heart Failure (CHF)

Intervention(s)

Procedure: Standard care

Primary Outcome(s)

Change of the percentage of clinically stable patients whose therapy regimen adheres to ESC guideline recommendations before and after specialist referral [Time Frame: Baseline, Month 6]

Secondary Outcome(s)

Change of EQ-5D total and individual sub-scores between baseline and 6 months later, between baseline and 10 months later [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Number of patients in different living conditions [Time Frame: Baseline (Visit 1)]

Number of patients with smoking status [Time Frame: Baseline (Visit 1)]

Percentages of clinically stable patients for whom the cardiologist and/or primary care physician optimizes treatment post referral, stratified according to key baseline characteristics [Time Frame: 6 and 10 months]

Change of NT-proBNP levels in clinically stable CHF patients with and without treatment optimization 10 months after baseline [Time Frame: Baseline (Visit 1) and 10 months]

Mean dose of previously taken and current use of concomitant compound [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Duration of treatment with device type [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Number of patients at different educational level [Time Frame: Baseline (Visit 1)]

Number of patients from different geographical regions [Time Frame: Baseline (visit 1)]

Number of patients in different age categories [Time Frame: Baseline]

Number of patients with different ethnicity [Time Frame: Baseline (Visit 1)]

Percentages of clinically stable patients [Time Frame: Baseline (Visit 1)]

Number of patients with cardiovascular and non-cardiovascular co-morbidities [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Number of patients with previously taken and current use of concomitant compound [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Number of patients by primary care physicians' prescription practice per country/region [Time Frame: Baseline, 6 months, 10 months]

Number of device type [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Number of patients in different employment status [Time Frame: Baseline (Visit 1)]

Change in KCCQ total and individual sub-scores between baseline and 6 months later, between and 10 months later [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Duration of Heart Failure [Time Frame: Baseline (Visit 1)]

Number of heart failure (HF)-related hospitalizations in the previous 12 months prior to baseline, and during the study [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Number of patients per primary etiology of Heart Failure [Time Frame: Baseline (Visit 1)]

Number of patients by cardiologist prescription practice per country/region [Time Frame: 6 months]

Duration of previously taken and currently use of concomitant compound [Time Frame: Baseline (Visit 1), 6 months, 10 months]

Number of patients with different gender categories [Time Frame: Baseline (Visit 1)]

Number of patients with different NT-proBNP level categories [Time Frame: One measurement in all consecutive patients at baseline (Visit 1)]

Number of patients with health insurance status [Time Frame: Baseline (Visit 1)]

Secondary ID(s)

CLCZ696B3402

2016-000473-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors