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AzTrials

Chronic Heart Failure (CHF)PREFERNCT02807857

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

A study of Chronic Heart Failure (CHF), run by Novartis Pharmaceuticals at 191 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure (CHF)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,415 participants
Where
191 sitesin 18 countries
Study dates
7 Jul 2016to 23 Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

191 sites in 18 countries.

191 sites in 18 countries

Belgium36 sites

  • Novartis Investigative Site

    Aarschot, 3200

  • Novartis Investigative Site

    Alveringem, 8691

  • Novartis Investigative Site

    Binkom, BEL, 3211

  • Novartis Investigative Site

    Boezinge, 8904

  • Novartis Investigative Site

    Bruxe, 1080

  • Novartis Investigative Site

    Buggenhout, Belgium, 9255

  • Novartis Investigative Site

    Deinze, 9800

  • Novartis Investigative Site

    Deurne, 2100

  • Novartis Investigative Site

    Diksmuide, 8600

  • Novartis Investigative Site

    Ezemaal-Neerwinden, 3400

  • Novartis Investigative Site

    Gozée, BEL, 6534

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Hasselt, Belgium, 3500

  • Novartis Investigative Site

    Herzele, 9550

  • Novartis Investigative Site

    Kluisbergen, Belgium, 9690

  • Novartis Investigative Site

    Landen, 3400

  • Novartis Investigative Site

    Leefdaal, 3060

  • Novartis Investigative Site

    Linkebeek, BEL, 1630

  • Novartis Investigative Site

    Linkebeek, 1630

  • Novartis Investigative Site

    Lommel, 3920

  • Novartis Investigative Site

    Maasmechelen, 3630

  • Novartis Investigative Site

    Mont-sur-Marchienne, 6032

  • Novartis Investigative Site

    Nazareth, 9810

  • Novartis Investigative Site

    Oosteeklo, 9988

  • Novartis Investigative Site

    Oostham, BEL, 3945

  • Novartis Investigative Site

    Ostend

  • Novartis Investigative Site

    Oudenaarde, 9700

  • Novartis Investigative Site

    Saint-Médard, 6887

  • Novartis Investigative Site

    Stoumont, 4987

  • Novartis Investigative Site

    Tessenderlo, 3980

  • Novartis Investigative Site

    Thuilles, 6536

  • Novartis Investigative Site

    Tielt-Winge, 3390

  • Novartis Investigative Site

    Tremelo, 3120

  • Novartis Investigative Site

    Vilvoorde, 1800

  • Novartis Investigative Site

    Waregem, 8790

  • Novartis Investigative Site

    Zichem, BEL, 3271

Other trials in Belgium

Poland21 sites

  • Novartis Investigative Site

    Bialystok, 15-746

  • Novartis Investigative Site

    Bialystok, 15-867

  • Novartis Investigative Site

    Bielawa, 58-260

  • Novartis Investigative Site

    Bydgoszcz, 85-021

  • Novartis Investigative Site

    Chełm, POL, 22-100

  • Novartis Investigative Site

    Dzierżoniów, 58-200

  • Novartis Investigative Site

    Kartuzy, POL, 83-300

  • Novartis Investigative Site

    Katowice, 40-018

  • Novartis Investigative Site

    Krakow, 30 415

  • Novartis Investigative Site

    Krakow, 30-664

  • Novartis Investigative Site

    Krakow, 31-061

  • Novartis Investigative Site

    Lublin, 20-094

  • Novartis Investigative Site

    Miasteczko Śląskie, 42-610

  • Novartis Investigative Site

    Poznan, 61-388

  • Novartis Investigative Site

    Warsaw, POL, 00-874

  • Novartis Investigative Site

    Warsaw, 01-493

  • Novartis Investigative Site

    Warsaw, 01-887

  • Novartis Investigative Site

    Warsaw, 03 185

  • Novartis Investigative Site

    Wieleń, 64-730

  • Novartis Investigative Site

    Wroclaw, 54-703

  • Novartis Investigative Site

    Zgierz, 95-100

Other trials in Poland

France20 sites

  • Novartis Investigative Site

    Arras, 62000

  • Novartis Investigative Site

    Bersée, 59254

  • Novartis Investigative Site

    Breteuil Sur Seine, France, 27160

  • Novartis Investigative Site

    Cannes, 06400

  • Novartis Investigative Site

    Chantepie, 35135

  • Novartis Investigative Site

    Colombiers, 31770

  • Novartis Investigative Site

    Coursan, 11110

  • Novartis Investigative Site

    Erquy, 22430

  • Novartis Investigative Site

    La Seyne-sur-Mer, 83500

  • Novartis Investigative Site

    Laval, 53000

  • Novartis Investigative Site

    Les Pennes-Mirabeau, 13170

  • Novartis Investigative Site

    Nègrepelisse, 82800

  • Novartis Investigative Site

    Orthez, 64300

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Paris, 75020

  • Novartis Investigative Site

    Rosiers d'Egleton, 19300

  • Novartis Investigative Site

    Saint-Orens-de-Gameville, 31650

  • Novartis Investigative Site

    Salles, 33770

  • Novartis Investigative Site

    Six-Fours-les-Plages, 83140

  • Novartis Investigative Site

    Strasbourg, 67200

Other trials in France

Spain20 sites

  • Novartis Investigative Site

    A Coruña, 15007

  • Novartis Investigative Site

    A Estrada, Pontevedra, 36681

  • Novartis Investigative Site

    Alcúdia, Balearic Islands, 07400

  • Novartis Investigative Site

    Alicante, 03540

  • Novartis Investigative Site

    Burriana, Castellon, 12530

  • Novartis Investigative Site

    Cambre, A Coruna, 15660

  • Novartis Investigative Site

    El Cañaveral, Caceres, 10820

  • Novartis Investigative Site

    El Parador de Las Hortichiuela, Almeria, 04720

  • Novartis Investigative Site

    Madrid, 28030

  • Novartis Investigative Site

    Madrid, 28032

  • Novartis Investigative Site

    Madrid, 28033

  • Novartis Investigative Site

    Monteporeiro, Pontevedra, 36162

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33009

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33013

  • Novartis Investigative Site

    Panxón, 36340

  • Novartis Investigative Site

    Parla, Madrid, 28982

  • Novartis Investigative Site

    Petrel, Alicante, 03610

  • Novartis Investigative Site

    Porto do Son, A Coruña, 15970

  • Novartis Investigative Site

    Puerto Real, Cadiz, 11510

  • Novartis Investigative Site

    Telde, Las Palmas de Gran Canaria, 35215

Other trials in Spain

Croatia15 sites

  • Novartis Investigative Site

    Bizovac, 31222

  • Novartis Investigative Site

    HRV, Croatia, 10000

  • Novartis Investigative Site

    HRV, Croatia, 31000

  • Novartis Investigative Site

    HRV, Croatia, 44320

  • Novartis Investigative Site

    HRV, 42000

  • Novartis Investigative Site

    Krasica, 51224

  • Novartis Investigative Site

    Osijek, 31000

  • Novartis Investigative Site

    Rijeka, HRV, 51000

  • Novartis Investigative Site

    Rijeka, 51000

  • Novartis Investigative Site

    Slavonski Brod, 35000

  • Novartis Investigative Site

    Velika Kopanica, 35221

  • Novartis Investigative Site

    Viškovo, 51216

  • Novartis Investigative Site

    Višnjevac, HRV, 31220

  • Novartis Investigative Site

    Zagreb, HRV, 10000

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Hungary15 sites

  • Novartis Investigative Site

    Balatonkeresztúr, 8647

  • Novartis Investigative Site

    Budapest, 1136

  • Novartis Investigative Site

    Csongrád, 6640

  • Novartis Investigative Site

    Érd, 2030

  • Novartis Investigative Site

    Felsőrajk, 8767

  • Novartis Investigative Site

    Hosszúhetény, 7694

  • Novartis Investigative Site

    Kecskemét, 6000

  • Novartis Investigative Site

    Korondi, 6726

  • Novartis Investigative Site

    Nyíregyháza, 4400

  • Novartis Investigative Site

    Pécs, 7632

  • Novartis Investigative Site

    Szabadsag, 6756

  • Novartis Investigative Site

    Szeged-Szoreg, H-6771

  • Novartis Investigative Site

    Székesfehérvár, 8000

  • Novartis Investigative Site

    Törökbálint, 2045

  • Novartis Investigative Site

    Zákányszék, 6787

Other trials in Hungary

Russia11 sites

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    Moscow, 121374

  • Novartis Investigative Site

    Moscow, 121552

  • Novartis Investigative Site

    Moscow, 127015

  • Novartis Investigative Site

    Moscow, 127206

  • Novartis Investigative Site

    Petrozavodsk, 185019

  • Novartis Investigative Site

    Saint Petersburg, 197110

  • Novartis Investigative Site

    Saint Petersburg, 199106

  • Novartis Investigative Site

    Ufa, 450000

  • Novartis Investigative Site

    Vladivostok, 690002

  • Novartis Investigative Site

    Yaroslavl, 150047

Other trials in Russia

Norway10 sites

  • Novartis Investigative Site

    Flisa, 2270

  • Novartis Investigative Site

    Hamar, 2317

  • Novartis Investigative Site

    Hønefoss, 3515

  • Novartis Investigative Site

    Kirkenær, 2260

  • Novartis Investigative Site

    Lierskogen, N-3420

  • Novartis Investigative Site

    Lørenskog, 1473

  • Novartis Investigative Site

    Løten, 2340

  • Novartis Investigative Site

    Noetteroey, 3163

  • Novartis Investigative Site

    Ostereidet, Norway, 5993

  • Novartis Investigative Site

    Skien, 3734

Other trials in Norway

Slovenia9 sites

  • Novartis Investigative Site

    Ivančna Gorica, 1295

  • Novartis Investigative Site

    Kranj, 4000

  • Novartis Investigative Site

    Ljubljana, 1000

  • Novartis Investigative Site

    Maribor, 2000

  • Novartis Investigative Site

    Pesnica, 2211

  • Novartis Investigative Site

    Slovenske Konjice, 3210

  • Novartis Investigative Site

    Spodnji Duplek, 2241

  • Novartis Investigative Site

    Vrhnika, 1360

  • Novartis Investigative Site

    Žalec, 3310

Other trials in Slovenia

Lithuania7 sites

  • Novartis Investigative Site

    Alytus, LT-62386

  • Novartis Investigative Site

    Kaunas, LTU, LT 45488

  • Novartis Investigative Site

    Kaunas, LTU, LT 50161

  • Novartis Investigative Site

    Kaunas, LT-49387

  • Novartis Investigative Site

    Kaunas, LT-49449

  • Novartis Investigative Site

    Klaipėda, LTU, 92304

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Portugal7 sites

  • Novartis Investigative Site

    Cantanhede, 3060 123

  • Novartis Investigative Site

    Leça da Palmeira, 4450 586

  • Novartis Investigative Site

    Lisbon, 1200 375

  • Novartis Investigative Site

    Lisbon, 1250 210

  • Novartis Investigative Site

    Lisbon, 1800 192

  • Novartis Investigative Site

    Oeiras, 2780 163

  • Novartis Investigative Site

    Seixal, Bairro Novo, 2840 481

Other trials in Portugal

Estonia5 sites

  • Novartis Investigative Site

    Paide, 72713

  • Novartis Investigative Site

    Sõmeru, EST, 44201

  • Novartis Investigative Site

    Tallinn, 10138

  • Novartis Investigative Site

    Tallinn, 11911

  • Novartis Investigative Site

    Tallinn, 13415

Other trials in Estonia

Latvia5 sites

  • Novartis Investigative Site

    Jelgava, LVA, LV-3001

  • Novartis Investigative Site

    Riga, LVA, LV 1010

  • Novartis Investigative Site

    Riga, 1012

  • Novartis Investigative Site

    Riga, LV-1006

  • Novartis Investigative Site

    Riga, LV-1021

Other trials in Latvia

Malta3 sites

  • Novartis Investigative Site

    Rabat

  • Novartis Investigative Site

    Xaghra, Gozo, XRA 2405

  • Novartis Investigative Site

    Xewkija, Gozo, VCT 110

Other trials in Malta

Cyprus2 sites

  • Novartis Investigative Site

    Nicosia, 2048

  • Novartis Investigative Site

    Nicosia, 2540

Other trials in Cyprus

Denmark2 sites

  • Novartis Investigative Site

    Præstø, 4720

  • Novartis Investigative Site

    Skive, 7800

Other trials in Denmark

Italy2 sites

  • Novartis Investigative Site

    Gatteo, FC, 47043

  • Novartis Investigative Site

    Grumello del Monte, BG, 24064

Other trials in Italy

Israel1 site

  • Novartis Investigative Site

    Beersheba, 8477713

Other trials in Israel

About this study

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.

Read the detailed description

In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF < or = 40%) and NT-proBNP level > or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..

Being tested
Standard care
Keywords
low-interventional observational study,, CHF,, heart failure,, primary care,, ESC guidelines,, Europe,, NT-proBNP,, reduced ventricular ejection fraction (EF),
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard careProcedure or surgery

    Patients will receive the treatment that their primary care physician has decided to prescribe for their disease

Study groups in NCT02807857
Study groupRoleWhat they receive
Patients' heart failure and non-heart failureOtherNo treatments are stipulated by this protocol - patients' HF and non-HF treatments will be observed throughout the study. The patients' treatment is entirely in the discretion of the primary care physicians
Receives: Procedure: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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.

    Measured: Baseline (Visit 1)

  2. 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

    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.

    Measured: Month 6

Secondary outcomes (24)

  1. Duration of Heart Failure

    The duration of Heart Failure was collected at Baseline (Visit 1).

    Measured: Baseline (Visit 1)

  2. Number of Patients With Current Use of Concomitant Compound

    Use of concomitant compounds were collected at baseline (Visit 1)

    Measured: Baseline (Visit 1)

  3. Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2

    Use of concomitant compounds were collected at 6 months (Visit 2)

    Measured: 6 months (Visit 2)

  4. Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics

    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.

    Measured: 6 months

  5. Number of Patients With Different NT-proBNP Level Categories

    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).

    Measured: One measurement in all consecutive patients at baseline (Visit 1)

  6. Percentages of Clinically Stable Patients

    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.

    Measured: Baseline (Visit 1)

  7. Number of Patients by Cardiologist Prescription Practice Per Country/Region

    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.

    Measured: 6 months

  8. Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline

    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.

    Measured: 10 months

  9. 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)

    Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF).

    Measured: Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)

  10. 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)

    The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure.

    Measured: Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)

  11. Number of Patients in Different Living Conditions

    Living conditions were collected at Baseline (Visit 1).

    Measured: Baseline (Visit 1)

  12. Number of Patients in Different Employment Status

    Employment status was collected at Baseline (Visit 1).

    Measured: Baseline (Visit 1)

  13. Number of Patients With Smoking Status

    Smoking status was collected at baseline (visit 1).

    Measured: Baseline (Visit 1)

  14. Number of Patients From Different Geographical Regions

    Geographic regions were collected at Baseline (Visit 1).

    Measured: Baseline (visit 1)

  15. Number of Patients With Health Insurance Status

    Health insurance status was collected at Baseline (Visit 1).

    Measured: Baseline (Visit 1)

  16. Number of Patients at Different Educational Level

    Educational level was collected at Baseline (Visit 1).

    Measured: Baseline (Visit 1)

  17. Number of Patients Per Primary Etiology of Heart Failure

    The primary etiology of Heart Failure was collected at Baseline (Visit 1).

    Measured: Baseline (Visit 1)

  18. Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study

    HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline.

    Measured: Baseline (Visit 1), 6 months, 10 months

  19. Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities

    Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1)

    Measured: Baseline (Visit 1)

  20. Mean Dose of Previously Taken and Current Use of Concomitant Medications

    Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline

    Measured: Baseline (Visit 1), 6 months, 10 months

  21. Number of Heart Failure (HF) Treatment Combinations

    The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1).

    Measured: Baseline (Visit 1)

  22. Duration of Treatment With Device Type

    The duration of treatment with device type was collected at baseline (Visit 1)

    Measured: Baseline (Visit 1)

  23. Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds

    Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected

    Measured: Baseline (Visit 1)

  24. Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region

    For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented.

    Measured: Baseline (Visit 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2016 (estimated)
  2. Study start7 Jul 2016
  3. Primary completion23 Mar 2018
  4. Study completion23 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02807857
Sponsor's protocol ID
CLCZ696B3402
Other IDs
2016-000473-20, 2016
Acronym
PREFER
Status last verified
Feb 2021
First submitted
17 Jun 2016
Last updated
24 Feb 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A study of Chronic Heart Failure (CHF), run by Novartis Pharmaceuticals at 191 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in Belgium, Poland, France, Spain, Croatia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Baseline (Visit 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02807857.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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