N/A
N=1,415
A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
Chronic Heart Failure (CHF)
Bottom Line
View on ClinicalTrials.gov: NCT02807857 ↗Enrolled (actual)
1,415
Serious AEs
10.2%
Results posted
Jan 2021
Primary outcome: Primary: Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) — 110; 59; 802; 523 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard care (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist) |
110; 59; 802; 523; 503; 279 | — |
| PRIMARY Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose |
3.3; 0.8; 79.2; 86.7 | — |
| SECONDARY Duration of Heart Failure |
896; 549; 517; 312 | — |
| SECONDARY Number of Patients With Current Use of Concomitant Compound |
934; 625; 981; 602; 834; 491 | — |
| SECONDARY Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 |
581; 533; 476; 423; 221; 238 | — |
| SECONDARY Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics |
45.1; 30.7; 6.3; 17.9 | — |
| SECONDARY Number of Patients With Different NT-proBNP Level Categories |
495; 0; 135; 130; 97; 93 | — |
| SECONDARY Percentages of Clinically Stable Patients |
96.9; 3.1; 63.2; 36.8 | — |
| SECONDARY Number of Patients by Cardiologist Prescription Practice Per Country/Region |
198; 525 | — |
| SECONDARY Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline |
2753; 2245; -504 | — |
| SECONDARY Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) |
60; 60; 0.81; 0.79; 0.80; 0.00 | — |
| SECONDARY Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months) |
77.1; 74.0; 72.1; 68.8; 70.1; 66.1 | — |
| SECONDARY Number of Patients in Different Living Conditions |
313; 204; 817; 481; 264; 159 | — |
| SECONDARY Number of Patients in Different Employment Status |
0; 0; 49; 28; 144; 51 | — |
| SECONDARY Number of Patients With Smoking Status |
779; 500; 205; 113; 427; 246 | — |
| SECONDARY Number of Patients From Different Geographical Regions |
226; 173; 201; 114; 169; 95 | — |
| SECONDARY Number of Patients With Health Insurance Status |
1168; 712; 29; 22; 171; 98 | — |
| SECONDARY Number of Patients at Different Educational Level |
396; 248; 730; 421; 257; 173 | — |
| SECONDARY Number of Patients Per Primary Etiology of Heart Failure |
860; 541; 553; 320 | — |
| SECONDARY Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study |
383; 262; 0; 18; 0; 22 | — |
| SECONDARY Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities |
74.2; 75.8; 61.6; 58.8; 43.9; 44.4 | — |
| SECONDARY Mean Dose of Previously Taken and Current Use of Concomitant Medications |
— | — |
| SECONDARY Number of Heart Failure (HF) Treatment Combinations |
178; 166; 165; 82; 13; 20 | — |
| SECONDARY Duration of Treatment With Device Type |
— | — |
| SECONDARY Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds |
0.65; 0.57; 0.31 | — |
| SECONDARY Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region |
— | — |
Summary
This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02807857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.