Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.

Официальное название

Impact of Combined cARdio-pUlmonary aSsessment on COPD Clinical Management: the ICARUS Study

Обзор

The goal of this randomized clinical trial is to learn whether a combined cardio-pulmonary assessment improves cardiac function, exercise capacity, cardiac biomarkers and health-related quality of life in adults with mild-to-moderate chronic obstructive pulmonary disease (COPD) who are at high cardiovascular risk or have established cardiovascular disease. The main questions it aims to answer are: * Does the combined cardio-pulmonary assessment improve mean left ventricular ejection fraction (EF) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean 6-minute walk distance (6MWD) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment reduce mean NT-proBNP over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score over 12 months compared with standard respiratory care? Researchers will compare a combined cardio-pulmonary assessment to standard respiratory care to see whether the integrated approach leads to greater improvements in EF, 6MWD, NT-proBNP, and KCCQ-12. Participants will: * Be randomly assigned to receive either a combined cardio-pulmonary assessment or standard respiratory care * Complete a baseline visit that includes clinical assessment, respiratory function testing, blood tests (including NT-proBNP), a 6-minute walk test, and the KCCQ-12 questionnaire * Undergo cardiovascular evaluation (electrocardiogram and transthoracic echocardiography) if assigned to the combined assessment group * Attend follow-up evaluation at 12 months, repeating the same assessments according to their assigned group

Вмешательства

• Другое Structured combined cardio-pulmonary clinical management strategy
  This intervention consists of a structured combined cardio-pulmonary outpatient evaluation in patients with COPD and either high cardiovascular risk or established cardiovascular disease. In addition to standard respiratory assessment (clinical history, lung function testing, 6-minute walk test, laboratory tests and guideline-based management), participants undergo a structured cardiovascular evaluation including ECG and transthoracic echocardiography. Treatment optimization is performed accordi
• Другое Standard Respiratory Management
  Participants receive standard COPD outpatient evaluation including clinical history, symptom assessment (CAT, mMRC), lung function testing, 6-minute walk test, laboratory testing and guideline-based respiratory management. No structured cardiovascular assessment (ECG or echocardiography) is systematically performed as part of the study intervention. Cardiovascular referral may occur only according to usual clinical practice.

Первичные конечные точки

• Change in Left Ventricular Ejection Fraction (EF) [Срок оценки: Baseline to 12 months]
• Change in 6-Minute Walk Distance (6MWD) [Срок оценки: Baseline to 12 months]
• Change in NT-proBNP Levels [Срок оценки: Baseline to 12 months]
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (5)

• Number of new cardiovascular diseases diagnoses [Срок оценки: Up to 12 months]
• Annual COPD Exacerbation Rate [Срок оценки: 12 months]
• Change in Forced Expiratory Volume in 1 Second (FEV1) [Срок оценки: Baseline to 12 months]
• Emergency department visits or hospitalizations for cardiovascular worsening [Срок оценки: Up to 12 months]
• Proportion of participants achieving KCCQ-12 MCID improvement [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

Patients enrolled in the study should be diagnosed as COPD according to international recommendations (1) with the following features:

• Post-bronchodilator FEV1 ≥ 50% or FEV1 z ≥ -2.5
• Age > 40 years

Additionally, enrolled patients must fulfill at least one of the following cardiovascular criteria:

• Very high cardiovascular risk

• according to SCORE2 (12)for patient < 70 years old and defined as follows:

• Patients < 50 years old > 7.5%
• Patients 50-69 years old > 10%
• according to SCORE OP 2 (13) calculator for patients > 70 years old and defined as > 15%
• History of ischemic heart disease
• Chronic or transient atrial fibrillation
• Chronic heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (EF > 40%) (14)

Критерии исключения

• Post-bronchodilator FEV1 < 50% or FEV1 z < -2.5
• LTOLT
• Active neoplasm
• Patient unable to perform lung function
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3. PMID 21315441
• McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30. PMID 25176015
• Docherty KF, Jhund PS, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, DeMets DL, Sabatine MS, Bengtsson O, Sjostrand M, Langkilde AM, Desai AS, Diez M, Howlett JG, Katova T, Ljungman CEA, O'Meara E, Petrie MC, Schou M, Verma S, Vinh PN, Solomon SD, McMurray JJV. Effects of dapagliflozin in DAPA-HF according to background heart failure therapy. Eur Heart J. 2020 Jul 1;41(25):2379-23 PMID 32221582
• Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.105 PMID 24716680
• Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir PMID 25359355
• O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454. PMID 19351941
• Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1. PMID 20801500
• Stienen S, Salah K, Moons AH, Bakx AL, van Pol P, Kortz RAM, Ferreira JP, Marques I, Schroeder-Tanka JM, Keijer JT, Bayes-Genis A, Tijssen JGP, Pinto YM, Kok WE. NT-proBNP (N-Terminal pro-B-Type Natriuretic Peptide)-Guided Therapy in Acute Decompensated Heart Failure: PRIMA II Randomized Controlled Trial (Can NT-ProBNP-Guided Therapy During Hospital Admission for Acute Decompensated Heart Failure PMID 29242350

Идентификаторы

NCT: NCT07481825 · 2447/CEL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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