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

NCT02807857 | Completed Results

• 2 other identifiers: CLCZ696B34022016-000473-20
• Study Type: interventional
• Target: 1,415
• Locations: 17 countries
• Sites: 171

Brief 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.

Conditions

Chronic Heart Failure (CHF)

Keywords

low-interventional observational study,; CHF,; heart failure,; primary care,; ESC guidelines,; Europe,; NT-proBNP,; reduced ventricular ejection fraction (EF),

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Visit 1)

• 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.

  Month 6

Secondary Outcomes (24)

• Duration of Heart Failure

  Baseline (Visit 1)

• Number of Patients With Current Use of Concomitant Compound

  Baseline (Visit 1)

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

  6 months (Visit 2)

• 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

• Number of Patients With Different NT-proBNP Level Categories

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

Study Arms (1)

Patients' heart failure and non-heart failure

OTHER

No 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

Procedure: Standard care

Interventions

Standard care PROCEDURE

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

Patients' heart failure and non-heart failure

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (191)

Novartis Investigative Site

Kluisbergen, Belgium, 9690, Belgium

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Novartis Investigative Site

Binkom, BEL, 3211, Belgium

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Novartis Investigative Site

Gozée, BEL, 6534, Belgium

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Novartis Investigative Site

Linkebeek, BEL, 1630, Belgium

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Novartis Investigative Site

Oostham, BEL, 3945, Belgium

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Novartis Investigative Site

Zichem, BEL, 3271, Belgium

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Novartis Investigative Site

Aarschot, 3200, Belgium

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Novartis Investigative Site

Alveringem, 8691, Belgium

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Novartis Investigative Site

Boezinge, 8904, Belgium

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Novartis Investigative Site

Bruxe, 1080, Belgium

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Novartis Investigative Site

Buggenhout, Belgium, 9255, Belgium

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Novartis Investigative Site

Deinze, 9800, Belgium

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Novartis Investigative Site

Deurne, 2100, Belgium

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Novartis Investigative Site

Diksmuide, 8600, Belgium

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Novartis Investigative Site

Ezemaal-Neerwinden, 3400, Belgium

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Novartis Investigative Site

Hasselt, 3500, Belgium

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Novartis Investigative Site

Hasselt, Belgium, 3500, Belgium

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Novartis Investigative Site

Herzele, 9550, Belgium

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Landen, 3400, Belgium

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Leefdaal, 3060, Belgium

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Linkebeek, 1630, Belgium

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Lommel, 3920, Belgium

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Maasmechelen, 3630, Belgium

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Mont-sur-Marchienne, 6032, Belgium

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Novartis Investigative Site

Nazareth, 9810, Belgium

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Oosteeklo, 9988, Belgium

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Ostend, Belgium

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Oudenaarde, 9700, Belgium

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Saint-Médard, 6887, Belgium

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Stoumont, 4987, Belgium

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Tessenderlo, 3980, Belgium

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Thuilles, 6536, Belgium

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Tielt-Winge, 3390, Belgium

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Tremelo, 3120, Belgium

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Vilvoorde, 1800, Belgium

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Waregem, 8790, Belgium

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HRV, Croatia, 10000, Croatia

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HRV, Croatia, 31000, Croatia

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HRV, Croatia, 44320, Croatia

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Rijeka, HRV, 51000, Croatia

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Višnjevac, HRV, 31220, Croatia

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Zagreb, HRV, 10000, Croatia

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Bizovac, 31222, Croatia

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HRV, 42000, Croatia

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Krasica, 51224, Croatia

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Osijek, 31000, Croatia

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Rijeka, 51000, Croatia

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Slavonski Brod, 35000, Croatia

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Velika Kopanica, 35221, Croatia

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Viškovo, 51216, Croatia

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Zagreb, 10000, Croatia

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Nicosia, 2048, Cyprus

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Nicosia, 2540, Cyprus

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Præstø, 4720, Denmark

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Skive, 7800, Denmark

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Sõmeru, EST, 44201, Estonia

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Paide, 72713, Estonia

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Tallinn, 10138, Estonia

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Tallinn, 11911, Estonia

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Tallinn, 13415, Estonia

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Breteuil Sur Seine, France, 27160, France

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Arras, 62000, France

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Bersée, 59254, France

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Cannes, 06400, France

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Chantepie, 35135, France

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Colombiers, 31770, France

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Coursan, 11110, France

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Erquy, 22430, France

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La Seyne-sur-Mer, 83500, France

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Laval, 53000, France

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Les Pennes-Mirabeau, 13170, France

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Nègrepelisse, 82800, France

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Orthez, 64300, France

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Paris, 75010, France

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Paris, 75020, France

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Rosiers d'Egleton, 19300, France

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Saint-Orens-de-Gameville, 31650, France

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Salles, 33770, France

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Six-Fours-les-Plages, 83140, France

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Strasbourg, 67200, France

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Balatonkeresztúr, 8647, Hungary

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Budapest, 1136, Hungary

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Csongrád, 6640, Hungary

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Érd, 2030, Hungary

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Felsőrajk, 8767, Hungary

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Hosszúhetény, 7694, Hungary

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Kecskemét, 6000, Hungary

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Korondi, 6726, Hungary

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Nyíregyháza, 4400, Hungary

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Pécs, 7632, Hungary

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Szabadsag, 6756, Hungary

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Szeged-Szoreg, H-6771, Hungary

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Székesfehérvár, 8000, Hungary

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Törökbálint, 2045, Hungary

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Zákányszék, 6787, Hungary

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Beersheba, 8477713, Israel

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Grumello del Monte, BG, 24064, Italy

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Gatteo, FC, 47043, Italy

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Jelgava, LVA, LV-3001, Latvia

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Riga, LVA, LV 1010, Latvia

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Riga, 1012, Latvia

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Riga, LV-1006, Latvia

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Riga, LV-1021, Latvia

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Kaunas, LTU, LT 45488, Lithuania

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Kaunas, LTU, LT 50161, Lithuania

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Klaipėda, LTU, 92304, Lithuania

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Alytus, LT-62386, Lithuania

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Kaunas, LT-49387, Lithuania

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Kaunas, LT-49449, Lithuania

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Vilnius, LT-08661, Lithuania

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Xagħra, Gozo, XRA 2405, Malta

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Xewkija, Gozo, VCT 110, Malta

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Rabat, Malta

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Ostereidet, Norway, 5993, Norway

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Flisa, 2270, Norway

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Hamar, 2317, Norway

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Hønefoss, 3515, Norway

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Kirkenær, 2260, Norway

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Lierskogen, N-3420, Norway

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Lørenskog, 1473, Norway

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Løten, 2340, Norway

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Noetteroey, 3163, Norway

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Skien, 3734, Norway

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Chełm, POL, 22-100, Poland

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Kartuzy, POL, 83-300, Poland

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Warsaw, POL, 00-874, Poland

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Bialystok, 15-746, Poland

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Bialystok, 15-867, Poland

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Bielawa, 58-260, Poland

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Bydgoszcz, 85-021, Poland

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Dzierżoniów, 58-200, Poland

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Katowice, 40-018, Poland

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Krakow, 30 415, Poland

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Krakow, 30-664, Poland

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Krakow, 31-061, Poland

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Lublin, 20-094, Poland

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Miasteczko Śląskie, 42-610, Poland

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Poznan, 61-388, Poland

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Warsaw, 01-493, Poland

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Warsaw, 01-887, Poland

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Warsaw, 03 185, Poland

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Wieleń, 64-730, Poland

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Wroclaw, 54-703, Poland

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Zgierz, 95-100, Poland

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Novartis Investigative Site

Seixal, Bairro Novo, 2840 481, Portugal

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Cantanhede, 3060 123, Portugal

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Leça da Palmeira, 4450 586, Portugal

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Lisbon, 1200 375, Portugal

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Lisbon, 1250 210, Portugal

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Novartis Investigative Site

Lisbon, 1800 192, Portugal

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Oeiras, 2780 163, Portugal

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Kazan', 420012, Russia

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Moscow, 121374, Russia

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Moscow, 121552, Russia

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Moscow, 127015, Russia

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Moscow, 127206, Russia

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Petrozavodsk, 185019, Russia

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Saint Petersburg, 197110, Russia

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Saint Petersburg, 199106, Russia

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Ufa, 450000, Russia

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Vladivostok, 690002, Russia

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Yaroslavl, 150047, Russia

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Ivančna Gorica, 1295, Slovenia

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Kranj, 4000, Slovenia

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Ljubljana, 1000, Slovenia

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Maribor, 2000, Slovenia

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Pesnica, 2211, Slovenia

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Slovenske Konjice, 3210, Slovenia

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Spodnji Duplek, 2241, Slovenia

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Vrhnika, 1360, Slovenia

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Žalec, 3310, Slovenia

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Cambre, A Coruna, 15660, Spain

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Porto do Son, A Coruña, 15970, Spain

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Petrel, Alicante, 03610, Spain

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El Parador de Las Hortichiuela, Almeria, 04720, Spain

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Alcúdia, Balearic Islands, 07400, Spain

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El Cañaveral, Caceres, 10820, Spain

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Puerto Real, Cadiz, 11510, Spain

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Burriana, Castellon, 12530, Spain

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Telde, Las Palmas de Gran Canaria, 35215, Spain

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Parla, Madrid, 28982, Spain

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A Estrada, Pontevedra, 36681, Spain

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Monteporeiro, Pontevedra, 36162, Spain

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Oviedo, Principality of Asturias, 33009, Spain

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Oviedo, Principality of Asturias, 33013, Spain

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A Coruña, 15007, Spain

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Alicante, 03540, Spain

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Madrid, 28030, Spain

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Madrid, 28032, Spain

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Madrid, 28033, Spain

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Panxón, 36340, Spain

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MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

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.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 21, 2016
• Study Start: July 7, 2016
• Primary Completion: March 23, 2018
• Study Completion: March 23, 2018
• Last Updated: February 24, 2021
• Results First Posted: January 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

CR (15); NO (10); DK (2); PT (7); ES (5); CY (2); FR (20); SL (9); BE (36); HU (15); LI (7); LA (5); RU (11); MA (3); IT (2); IL (1); PL (21)