COPD (Chronic Obstructive Pulmonary Disease)ICARUSNCT07481825
Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.
A study testing Structured combined cardio-pulmonary clinical management strategy and Standard Respiratory Management in people with COPD (Chronic Obstructive Pulmonary Disease) and Cardiovascular Disease, run by University of Bari Aldo Moro.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Cardiovascular Disease
- What is being tested?
- Structured combined cardio-pulmonary clinical management strategy and Standard Respiratory Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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)
Who cannot join
- Post-bronchodilator FEV1 < 50% or FEV1 z < -2.5
- LTOLT
- Active neoplasm
- Patient unable to perform lung function
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Combined cARdio-pUlmonary aSsessment on COPD Clinical Management: the ICARUS Study
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:
Read more
- 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
- Being tested
- Structured combined cardio-pulmonary clinical management strategy, Standard Respiratory Management
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Cardiovascular, cardio-pulmonary
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured combined cardio-pulmonary clinical management strategyOther
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 according to current respiratory and cardiovascular guidelines based on integrated multidisciplinary assessment. Follow-up is conducted at 12 months using the same integrated approach.
Standard Respiratory ManagementOther
Also called Standard of Care (SOC)
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Respiratory Assessment (SOC) | Active comparator | Participants receive standard COPD outpatient evaluation including clinical assessment, lung function testing, 6MWT, blood tests, and guideline-based management without structured cardiovascular assessment. Receives: Other: Standard Respiratory Management |
| Combined Cardio-Pulmonary Assessment | Active comparator | Participants receive standard COPD outpatient evaluation plus structured cardiovascular assessment including ECG and transthoracic echocardiography, with integrated cardio-pulmonary management. Receives: Other: Structured combined cardio-pulmonary clinical management strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (EF)
Mean change in left ventricular ejection fraction measured by transthoracic echocardiography from baseline to 12 months.
Measured: Baseline to 12 months
Change in 6-Minute Walk Distance (6MWD)
Mean change in 6-minute walk distance measured according to ERS/ATS standards from baseline to 12 months.
Measured: Baseline to 12 months
Change in NT-proBNP Levels
Mean change in plasma NT-proBNP levels from baseline to 12 months.
Measured: Baseline to 12 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score
Mean change in KCCQ-12 overall summary score from baseline to 12 months.
Measured: Baseline to 12 months
Secondary outcomes (5)
Number of new cardiovascular diseases diagnoses
Number of new cardiovascular disease diagnoses (heart failure, atrial fibrillation, coronary artery disease, systemic arterial hypertension) identified during follow-up.
Measured: Up to 12 months
Annual COPD Exacerbation Rate
Rate of COPD exacerbations during follow-up (events per patient-year), defined according to standard clinical criteria and recorded from clinical visits/medical records.
Measured: 12 months
Change in Forced Expiratory Volume in 1 Second (FEV1)
Mean change in post-bronchodilator FEV1 from baseline to 12 months measured by spirometry.
Measured: Baseline to 12 months
Emergency department visits or hospitalizations for cardiovascular worsening
Number of emergency department visits and/or hospitalizations due to cardiovascular disease worsening during follow-up.
Measured: Up to 12 months
Proportion of participants achieving KCCQ-12 MCID improvement
Number (proportion) of participants with KCCQ-12 improvement above the minimal clinically important difference (MCID): ≥7 points for HFpEF and ≥9 points for HFmrEF.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanna Elisiana Carpagnano, University of Bari Aldo Moro
- Investigators
- Giovanna Elisiana Carpagnano, MD, PhD, Study director, Institute of Respiratory Disease, Department of Translational Biomedicine and neuroscience, University "Aldo Moro", Bari, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481825
- Sponsor's protocol ID
- 2447/CEL
- Acronym
- ICARUS
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21315441McMurray 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.
PubMed 25176015Docherty 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):2379-2392. doi: 10.1093/eurheartj/ehaa183.
PubMed 32221582Pitt 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: 10.1056/NEJMoa1313731.
PubMed 24716680Holland 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 J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355O'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.
PubMed 19351941Swedberg 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.
PubMed 20801500Stienen 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 Reduce Mortality and Readmissions?). Circulation. 2018 Apr 17;137(16):1671-1683. doi: 10.1161/CIRCULATIONAHA.117.029882. Epub 2017 Dec 14.
PubMed 29242350Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL Jr, Mark DB, Pina IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne-Nickens P, O'Connor CM. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):713-720. doi: 10.1001/jama.2017.10565.
PubMed 28829876Lee DS, Straus SE, Farkouh ME, Austin PC, Taljaard M, Chong A, Fahim C, Poon S, Cram P, Smith S, McKelvie RS, Porepa L, Hartleib M, Mitoff P, Iwanochko RM, MacDougall A, Shadowitz S, Abrams H, Elbarasi E, Fang J, Udell JA, Schull MJ, Mak S, Ross HJ; COACH Trial Investigators. Trial of an Intervention to Improve Acute Heart Failure Outcomes. N Engl J Med. 2023 Jan 5;388(1):22-32. doi: 10.1056/NEJMoa2211680. Epub 2022 Nov 5.
PubMed 36342109Pieske B, Tschope C, de Boer RA, Fraser AG, Anker SD, Donal E, Edelmann F, Fu M, Guazzi M, Lam CSP, Lancellotti P, Melenovsky V, Morris DA, Nagel E, Pieske-Kraigher E, Ponikowski P, Solomon SD, Vasan RS, Rutten FH, Voors AA, Ruschitzka F, Paulus WJ, Seferovic P, Filippatos G. How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). Eur Heart J. 2019 Oct 21;40(40):3297-3317. doi: 10.1093/eurheartj/ehz641.
PubMed 31504452SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309.
PubMed 34120177Groenewegen A, Zwartkruis VW, Rienstra M, Zuithoff NPA, Hollander M, Koffijberg H, Oude Wolcherink M, Cramer MJ, van der Schouw YT, Hoes AW, Rutten FH, de Boer RA. Diagnostic yield of a proactive strategy for early detection of cardiovascular disease versus usual care in adults with type 2 diabetes or chronic obstructive pulmonary disease in primary care in the Netherlands (RED-CVD): a multicentre, pragmatic, cluster-randomised, controlled trial. Lancet Public Health. 2024 Feb;9(2):e88-e99. doi: 10.1016/S2468-2667(23)00269-4. Epub 2023 Dec 19.
PubMed 38134944Dransfield MT, Rowe SM, Johnson JE, Bailey WC, Gerald LB. Use of beta blockers and the risk of death in hospitalised patients with acute exacerbations of COPD. Thorax. 2008 Apr;63(4):301-5. doi: 10.1136/thx.2007.081893. Epub 2007 Oct 19.
PubMed 17951276Hawkins NM, Petrie MC, Macdonald MR, Jhund PS, Fabbri LM, Wikstrand J, McMurray JJ. Heart failure and chronic obstructive pulmonary disease the quandary of Beta-blockers and Beta-agonists. J Am Coll Cardiol. 2011 May 24;57(21):2127-38. doi: 10.1016/j.jacc.2011.02.020.
PubMed 21596228
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combined cARdio-pUlmonary aSsessment on COPD Clinical Management: the ICARUS Study
- ClinicalTrials.gov ID
- NCT07481825
- Acronym / sponsor ID
- ICARUS / 2447/CEL
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Cardiovascular, cardio-pulmonary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Respiratory Assessment (SOC) | Active comparator | Other: Standard Respiratory ManagementParticipants receive standard COPD outpatient evaluation including clinical assessment, lung function testing, 6MWT, blood tests, and guideline-based management without structured cardiovascular assessment. |
| Combined Cardio-Pulmonary Assessment | Active comparator | Other: Structured combined cardio-pulmonary clinical management strategyParticipants receive standard COPD outpatient evaluation plus structured cardiovascular assessment including ECG and transthoracic echocardiography, with integrated cardio-pulmonary management. |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- Post-bronchodilator FEV1 < 50% or FEV1 z < -2.5
- LTOLT
- Active neoplasm
- Patient unable to perform lung function
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured combined cardio-pulmonary clinical management strategyThis 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 according to current respiratory and cardiovascular guidelines based on integrated multidisciplinary assessment. Follow-up is conducted at 12 months using the same integrated approach. | Other | Combined Cardio-Pulmonary Assessment |
| Standard Respiratory ManagementAlso: Standard of Care (SOC)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. | Other | Standard Respiratory Assessment (SOC) |
Primary outcome
Change in Left Ventricular Ejection Fraction (EF)
Time frame: Baseline to 12 months
Mean change in left ventricular ejection fraction measured by transthoracic echocardiography from baseline to 12 months.
Change in 6-Minute Walk Distance (6MWD)
Time frame: Baseline to 12 months
Mean change in 6-minute walk distance measured according to ERS/ATS standards from baseline to 12 months.
Change in NT-proBNP Levels
Time frame: Baseline to 12 months
Mean change in plasma NT-proBNP levels from baseline to 12 months.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score
Time frame: Baseline to 12 months
Mean change in KCCQ-12 overall summary score from baseline to 12 months.
5 secondary outcomes
Number of new cardiovascular diseases diagnoses
Time frame: Up to 12 months
Annual COPD Exacerbation Rate
Time frame: 12 months
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline to 12 months
Emergency department visits or hospitalizations for cardiovascular worsening
Time frame: Up to 12 months
Proportion of participants achieving KCCQ-12 MCID improvement
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 21315441Abraham 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.
- Background: PubMed 25176015McMurray 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.
- Background: PubMed 32221582Docherty 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):2379-2392. doi: 10.1093/eurheartj/ehaa183.
- Background: PubMed 24716680Pitt 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: 10.1056/NEJMoa1313731.
- Background: PubMed 25359355Holland 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 J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 19351941O'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.
- Background: PubMed 20801500Swedberg 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.
- Background: PubMed 29242350Stienen 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 Reduce Mortality and Readmissions?). Circulation. 2018 Apr 17;137(16):1671-1683. doi: 10.1161/CIRCULATIONAHA.117.029882. Epub 2017 Dec 14.
- Background: PubMed 28829876Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL Jr, Mark DB, Pina IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne-Nickens P, O'Connor CM. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):713-720. doi: 10.1001/jama.2017.10565.
- Background: PubMed 36342109Lee DS, Straus SE, Farkouh ME, Austin PC, Taljaard M, Chong A, Fahim C, Poon S, Cram P, Smith S, McKelvie RS, Porepa L, Hartleib M, Mitoff P, Iwanochko RM, MacDougall A, Shadowitz S, Abrams H, Elbarasi E, Fang J, Udell JA, Schull MJ, Mak S, Ross HJ; COACH Trial Investigators. Trial of an Intervention to Improve Acute Heart Failure Outcomes. N Engl J Med. 2023 Jan 5;388(1):22-32. doi: 10.1056/NEJMoa2211680. Epub 2022 Nov 5.
- Background: PubMed 31504452Pieske B, Tschope C, de Boer RA, Fraser AG, Anker SD, Donal E, Edelmann F, Fu M, Guazzi M, Lam CSP, Lancellotti P, Melenovsky V, Morris DA, Nagel E, Pieske-Kraigher E, Ponikowski P, Solomon SD, Vasan RS, Rutten FH, Voors AA, Ruschitzka F, Paulus WJ, Seferovic P, Filippatos G. How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). Eur Heart J. 2019 Oct 21;40(40):3297-3317. doi: 10.1093/eurheartj/ehz641.
- Background: PubMed 34120177SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309.
- GOLD report 2024Link provided by the sponsor.
- Individual participant dataSharing planned: No
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COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanna Elisiana Carpagnano, MD, PhD study director
Institute of Respiratory Disease, Department of Translational Biomedicine and neuroscience, University "Aldo Moro", Bari, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Structured combined cardio-pulmonary clinical management strategy and Standard Respiratory Management in people with COPD (Chronic Obstructive Pulmonary Disease) and Cardiovascular Disease, run by University of Bari Aldo Moro.
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 12 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Elisiana Carpagnano, MD, PhD (+39 080559, elisiana.carpagnano@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (EF) (time frame: Baseline to 12 months). The study lists 4 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 NCT07481825, which also lists 22 linked publications.
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 19 Mar 2026.