Heart failure
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Normal group: Meet the part 1 of the following inclusion criteria + no symptoms of dyspnea 2) HFpEF group: Meet the following inclusion criteria Part 1 + Part 2 3) HFrEF group: Meet the following inclusion criteria Part 1 + Part 3 Part 1: 1) Age =18 years old; 2) Signed informed consent; Part 2: 1) There are symptoms of dyspnea (NYHA class II-IV), and the symptoms of dyspnea cannot be explained by non-cardiac or ischemic evidence; 2) Heart failure is the main factor limiting activity; 3) Imaging examination confirms that EF is =50%, and the clinical status shows no potential for deterioration of systolic function; 4) No continuous nitrate drug treatment or infrequent (less than once/week) sublingual nitroglycerin administration in the past 3 months; 5) Have one of the following situations in the past 12 months: ? NT-proBNP>400pg/ml or BNP>200pg/ml; ? Previously admitted to hospital due to HF, there were imaging manifestations of pulmonary congestion (pulmonary venous hypertension, vascular obstruction, interstitial edema, pleural effusion); ? LVEDP = 15 mmHg or PCWP = 20 mmHg at rest or PCWP = 25 mmHg during exercise measured by catheter; ? If ultrasound shows limited diastolic function or increased filling pressure, the diagnostic criteria should meet at least two of the following: 1-1: E/A>1.5 or the E/A value decreases>0.5 when performing Valsalva action 1-2: Peak deceleration time =140ms 1-3: Under sinus rhythm, the pulmonary vein flow velocity during systole is smaller than that during diastole (PVs58ml in male patients, LAV>52ml in female patients, or LA area>20cm2, or LA diameter>40 in male patients mm, LA diameter >38mm in female patients) 1-5: Pulmonary artery systolic pressure >40mmHg 1-6: Evidence of left ventricular hypertrophy; ? LV mass/BSA =96 for women or =116g/m2 for men; ? Relative chamber wall thickness =0.43; ? Left ventricular posterior wall thickness =0.9 in women or =1.0cm in men; 6) Able to move around independently without relying on a wheelchair, flat car, wheeled walker or crutches. Part 3: 1) There are symptoms of dyspnea (NYHA class II-IV), and the symptoms of dyspnea cannot be explained by non-cardiac or ischemic evidence; 2) Heart failure is the main factor limiting activity; 3) Imaging examination confirms that EF is =40%, and the clinical status shows no potential for deterioration of systolic function; 4) No continuous nitrate drug treatment or infrequent (less than once/week) sublingual nitroglycerin administration in the past 3 months; 5) Have one of the following situations in the past 12 months: ? NT-proBNP>400pg/ml or BNP>200pg/ml; ? Previously admitted to hospital due to HF, there were imaging manifestations of pulmonary congestion (pulmonary venous hypertension, vascular obstruction, interstitial edema, pleural effusion); ? LVEDP = 15 mmHg or PCWP = 20 mmHg at rest or PCWP = 25 mmHg during exercise measured by catheter; 6) Able to move around independently without relying on a wheelchair, flat car, wheeled walker or crutches.
Exclusion criteria
Exclusion criteria: 1) Failure to cooperate with the research for any reason, unable to complete the exhaled breath and peripheral blood collection process, or the researcher believes that it is not appropriate to be included in this trial; 2) Have any of the following medical or past histories: ? Acute coronary syndrome determined by ECG changes or markers of myocardial injury (such as troponin) within the past three months ? PCI, CABG or biventricular pacing within the past three months ? Primary hypertrophic cardiomyopathy ? Infiltrative cardiomyopathy (amyloidosis) ? Constrictive pericarditis or cardiac tamponade ? Active myocarditis ? Complex congenital heart disease ? Active vascular disease ? Mild or above aortic valve or mitral valve stenosis ? Moderate to severe valvular disease (prolapse, rheumatic) or severe mitral, tricuspid or aortic regurgitation ? Severe acute or chronic liver disease supported by any of the following indicators: hepatic encephalopathy, varicose veins, bleeding, INR>1.7 without anticoagulation; ? Have any of the following diseases or conditions that have the potential to affect exhaled VOCs: Diabetes (type 1 or type 2 with the following conditions: poor control requiring immediate treatment, such as diabetic ketoacidosis; 1 occurrence within 6 months One or more severe hypoglycemic events and/or one or more unperceived hypoglycemic events; HbA1c = 80 mmol; proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy requiring emergency treatment Medical history; treatment with premixed insulin or mealtime insulin or intensive insulin regimen: multiple daily injections of basal insulin and mealtime insulin or insulin pump treatment); renal impairment, defined as eGFR 4.0 mU/L at screening, or severe musculoskeletal disease. Obstructive sleep apnea; metabolic syndrome; family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2, active or untreated malignancy, or Clinically significant malignant tumors (except basal cell or squamous cell skin cancer, cervical cancer in situ, or prostate cancer in situ) have been in remission for less than 5 years; BMI = 30.0kg/m2; hospitalized due to worsening heart failure within the past 3 months. 3) Have any of the following symptoms or signs: ? Difficulty breathing due to severe COPD or ischemia ? Blood pressure and heart rate meet one of the following: SBP180mmHg DBP100mmHg Resting heart rate >110bpm; 4) Laboratory examination meets any of the following: ? Hemoglobin is less than 8.0g/dl ? The glomerular filtration rate in the latest test report is <20ml/min/1.73m2; 5) The range of ejection fraction determined by imaging examination is 40%~50% 6) Combined with terminal diseases excluding heart failure 7) Failure to follow the planned research process
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exhaled breath VOC characteristics; | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA cardiac function classification;NT-proBNP levels;Cardiac ultrasound evaluation indicators (LVEF, LAVI, LVWT, E/e’, tricuspid regurgitation peak velocity, etc.);Correlation between VOCs characteristics and cardiac function classification, NT-proBNP levels and ultrasound assessment indicators; | — |
Countries
China
Contacts
Public ContactTao Li
West China Hospital of Sichuan University
Outcome results
None listed