Trial · NCT02807857
A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
NCT02807857, Not applicable, Completed, Novartis Pharmaceuticals; results first posted 2021-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care. Trials, record NCT02807857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02807857
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
- NCT number
- NCT02807857
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,415 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Heart Failure (CHF)
- Interventions
- Standard care
- First posted
- 2016-06-21
- Last updated
- 2021-02-24
- Other registries' IDs
- eudract:2016-000473-20
- Results first posted
- 2021-01-05
- Limitations and caveats
- The recruitment was to be regarded as completed once approx. 2400 patients had entered the prospective period. However it was decided by Novartis to terminate the study prematurely, in March 2018.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Baseline (Visit 1) | Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type \& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose. |
| 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 | Month 6 | Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \> 35% at visit 1. Drug type \& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose. |
| Secondary | Duration of Heart Failure | Baseline (Visit 1) | The duration of Heart Failure was collected at Baseline (Visit 1). |
| Secondary | Number of Patients With Current Use of Concomitant Compound | Baseline (Visit 1) | Use of concomitant compounds were collected at baseline (Visit 1) |
| Secondary | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | 6 months (Visit 2) | Use of concomitant compounds were collected at 6 months (Visit 2) |
| 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 | 6 months | For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters. |
| Secondary | Number of Patients With Different NT-proBNP Level Categories | One measurement in all consecutive patients at baseline (Visit 1) | NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, \> 1200 pg/ml). |
| Secondary | Percentages of Clinically Stable Patients | Baseline (Visit 1) | Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion. |
| Secondary | Number of Patients by Cardiologist Prescription Practice Per Country/Region | 6 months | The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline. |
| Secondary | Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline | 10 months | At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Baseline (Visit 1) | Enrolled and Follow-up Set included. Due to missing left ventricular ejection fraction (LVEF) values, some patients could not be classified. | Participants | NUMBER |
| 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 | Month 6 | Follow-Up set | Percentage of Patients | NUMBER |
| SECONDARY | Duration of Heart Failure | Baseline (Visit 1) | Enrolled Set and Follow-Up Set | Participants | NUMBER |
| SECONDARY | Number of Patients With Current Use of Concomitant Compound | Baseline (Visit 1) | Enrolled Set and Follow-Up Set | Participants | NUMBER |
| SECONDARY | Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2 | 6 months (Visit 2) | Follow-Up Set | Participants | NUMBER |
| 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 | 6 months | Follow-Up Set | Percentage of Patients | NUMBER |
| SECONDARY | Number of Patients With Different NT-proBNP Level Categories | One measurement in all consecutive patients at baseline (Visit 1) | Enrolled Set and Follow-Up Set | Participants | NUMBER |
| SECONDARY | Percentages of Clinically Stable Patients | Baseline (Visit 1) | Enrolled Set | Percentage of Participants | NUMBER |
| SECONDARY | Number of Patients by Cardiologist Prescription Practice Per Country/Region | 6 months | Follow-Up Set | Number of Participants | NUMBER |
| SECONDARY | Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline | 10 months | Follow-Up Set | pg/mL | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group229
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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) | Enrolled Set | Level 1: Drug Type : Adherent | 110 | Participants | |
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) | Follow-Up Set | Level 1: Drug Type : Adherent | 59 | Participants | |
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) | Enrolled Set | Level 1: Drug type : Not Adherent | 802 | Participants | |
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) | Follow-Up Set | Level 1: Drug type : Not Adherent | 523 | Participants | |
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) | Enrolled Set | Patients missing LVEF values | 503 | Participants | |
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) | Follow-Up Set | Patients missing LVEF values | 279 | Participants | |
| 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 | Follow-Up Set | Adherence at V2, not adherent at V1 for drug type | 3.3 | Percentage of Patients | |
| 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 | Follow-Up Set | Adherence at V2, not adherent at V1:drug type/dose | 0.8 | Percentage of Patients | |
| 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 | Follow-Up Set | Adherence at V2 and V1 for drug type | 79.2 | Percentage of Patients | |
| 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 | Follow-Up Set | Adherence at Visit 1 for drug type & dose | 86.7 | Percentage of Patients |
1 to 10 of 229Source ClinicalTrials.gov
See all 229 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrolled Set | STARTED | Enrolled Patients | 1,415 | |
| Enrolled Set | COMPLETED | Enrolled Patients | 864 | |
| Enrolled Set | NOT COMPLETED | Enrolled Patients | 551 | |
| Follow-Up Set | STARTED | Enrolled Patients | 864 | |
| Follow-Up Set | COMPLETED | Enrolled Patients | 680 | |
| Follow-Up Set | NOT COMPLETED | Enrolled Patients | 184 |
Source ClinicalTrials.gov
Adverse events534
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Enrolled Set | 6 | 1,415 | |
| other | Anaemia | Blood and lymphatic system disorders | Follow-Up Set | 6 | 861 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Enrolled Set | 1 | 1,415 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Follow-Up Set | 1 | 861 | |
| other | Arteriosclerosis coronary artery | Cardiac disorders | Enrolled Set | 1 | 1,415 | |
| other | Arteriosclerosis coronary artery | Cardiac disorders | Follow-Up Set | 1 | 861 | |
| other | Atrial fibrillation | Cardiac disorders | Enrolled Set | 5 | 1,415 | |
| other | Atrial fibrillation | Cardiac disorders | Follow-Up Set | 5 | 861 | |
| other | Cardiac failure | Cardiac disorders | Enrolled Set | 5 | 1,415 | |
| other | Cardiac failure | Cardiac disorders | Follow-Up Set | 5 | 861 |
1 to 10 of 534Source ClinicalTrials.gov
See all 534 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enrolled Set | 32 | 1,415 |
| Total, all-cause mortality | Follow-Up Set | 30 | 861 |
| Total, other adverse events | Enrolled Set | 187 | 1,415 |
| Total, other adverse events | Follow-Up Set | 181 | 861 |
| Total, serious adverse events | Enrolled Set | 117 | 1,415 |
| Total, serious adverse events | Follow-Up Set | 114 | 861 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enrolled Set vs Follow-Up Set: deaths from any cause | Trial comparisons |
| Enrolled Set vs Follow-Up Set: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02807857
GET https://conductscience.org/api/trials/v1/NCT02807857/registered?page=2