COPD-HF

JRCT ID: jRCTs051200057

Registered date:24/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: CHF patients with COPD
• Date of first enrollment: 04/03/2021
• Target sample size: 54
• Study type: Interventional
• Intervention(s): Spiort(registered sign) Respimat(registered sign) Once a day, 2 inhalations (5 microgramme as tiotropium and 5 microgramme as olodaterol).

Outcome(s)

• Primary Outcome: Improvement of plasma BNP levels (baseline, after 12 weeks)

Secondary Outcome

1) Amount of change plasma BNP levels. (baseline, after 4 weeks)
2) Amount of change KCCQ (Kansas City Cardiomyopathy Questionnaire). (baseline, after 12 weeks)
3) Amount of change CAT (COPD Assessment Test) score. (baseline, after 12 weeks)
4) Amount of change mMRC (Modified Medical Research Council) Dyspnea Scale. (baseline, after 12 weeks)
5) Amount of change pulmonary function test (forced expiratory volume in one second (FEV1), percent predicted forced expiratory volume in one second (%FEV1), forced vital capacity (FVC), percent predicted forced vital capacity (%FVC), functional residual capacity (FRC), percent predicted functional residual capacity(%FRC)). (baseline, after 12 weeks)
6) Amount of change laboratory data (high sensitivity CRP, fibrinogen, IL-6, TNF alpha). (baseline, after 12 weeks)
7) Amount of change transthoracic echocardiography findings (left ventricle diastolic dimension (LVDd), left ventricle systolic dimension (LVDs), percent fractional shortening (%FS), LV ejection fraction (LVEF), left atrium dimension (LAD), inferior vena cava (IVC), tricuspid pressure gradient (TRPG), transmitral flow velocity pattern (TMF) (early diastolic filling velocity(E), atrial filling velocity(A), deceleration time(DcT), mitral annulus velocity (e'), E/e'). (baseline, after 12 weeks)
8) Total deaths. (after 12 weeks)
9) Cardiovascular events (cardiovascular mortalities, rehospitalization because of worsening of CHF, composite of cardiovascular mortalities and rehospitalization because of worsening of CHF). (after 12 weeks)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with CHF and COPD who are over 40 years old at the time of informed consent.
2) Patients with CHF and COPD.
3) Patients with written consent from the person.

Exclude criteria

1) Patients who have already received the drug medical treatment about LAMA or LABA and prohibited concomitant medications for COPD.
2) Patients who can not agree to the cessation of smoking.
3) Patients with an allergic history of tiotropium or lodaterol.
4) Patients with a history of the other severe respiratory diseases (asthma etc.).
5) Patients with dysuria of benign prostatic hyperplasia.
6) Patients were diagnosed with angle closure glaucoma.
7) Patients with acute heart failure (use of intravenous cardiotonic, diuretic and/or antiarrhythmic drugs) or NYHA classification class IV at the time of registration or administration.
8) Patients undergoing dose adjustment of digitalis, diuretics, aldosterone antagonists, cardiotonic drugs and antiarrhythmic drugs from 2 weeks before the start of administration.
9) Patients with lethal arrhythmia (sustained ventricular tachycardia lasting 30 seconds more or ventricular fibrillation).
10) Patients using mechanical circulatory support devices.
11) Patients waiting for heart transplant.
12) Patients waiting for cardiac surgery.
13) Patients within 24 weeks( 6 months) after onset of acute coronary syndrome, within 12 weeks(3 months) afterpercutaneous coronary intervention, or within 24 weeks( 6 months) after open heart surgery.
14) Patients who have started cardiac resynchronization therapy within 24 weeks(6 months).
15) Patients with severe renal dysfunction (estimated glomerular filtration ratio: eGFR less than 15 mL / min / 1.73m2) or undergoing maintenance hemodialysis or peritoneal dialysis.
16) Patients with severe liver dysfunction (T.Bil 10mg / dl or more, AST, ALT 500 IU / L or more, 5 times or more of ALP normal upper limit, PT 40% or less, bleeding tendency, liver failure symptoms such as consciousness disorder (fulminant hepatitis) cirrhosis, liver tumor, Jaundice lasting more than 24 weeks(6 months), Grade A equivalent to "Severity classification criteria for side effects of pharmaceuticals" 9).
17) Patients with decreased white blood cell count (less than 2500 / L) and platelet count (less than 80,000 / L).
18) Patients in a serious clinical condition and who are expected to live for < 3 years.
19) Patients with possible alcohol or drug abuse.
20) Patients who are pregnant or possibly pregnant.
21) Women who do not agree with contraception during the study.
22) Patients who are breast feeding.
23) Patients who have been enrolled in other clinical studies at the same time as this study (excluding observational studies such as registry studies).
24) Patients who are judged by the investigator or subinvestigators to not be suitable for participation in the study.

Related Information

• Primary Sponsor: Kitakaze Masafumi
• Secondary Sponsor: Nippon Boehringer Ingelheim Co.,Ltd.