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PRagmatic Observational feasibility study on Glucocorticoid treatment Reversing diurEtic reSiStance in Heart Failure: PROGRESS Study

PRagmatic Observational feasibility study on Glucocorticoid treatment Reversing diurEtic reSiStance in Heart Failure: PROGRESS Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077973
Enrollment
Unknown
Registered
2023-11-24
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Interventions

Experimental group:Glucocorticoid treatment

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: The acute decompensation phase of chronic heart failure is accompanied by severe fluid retention and is characterized by total, left, and/or right heart failure. For diuretic resistance candidate patients, the point urine sodium concentration, 24h urine total and point urine sodium concentration were measured at first, and after furosemide = 40mg intravenous injection, the urine volume at 1h, 2h and 6h and the point sodium concentration were measured, and the urine volume within 1-2h was =50-70mmol/L and the urine volume within 1-2h was =100-150ML/h, which met the diagnostic criteria for diuretic resistance. Urine sodium 71-109mmol/L, urine volume within 1-2h =100-150ML/h, in line with the standard of diuretic effect reduction. Application of loop diuretic furosemide = 80mg/d did not eliminate fluid retention (decongestion) in patients with severe heart failure, consistent with patients with diuretic resistance or reduced diuretic action in this trial. The age range is 18-80 years old. Blood pressure of all enrolled patients should be ?110/90mmHg, diuretic resistance ?5 days. 1. Patients with severe heart failure in coronary heart disease accompanied by diuretic resistance, the duration of heart failure = 1 month and diuretic resistance = 5 days, the continuous blood pressure = 110/90mmHg, accompanied by left ventricular enlargement, LVEF=0.40; 2. Patients with hypertensive heart disease and heart failure diuretic resistance, accompanied by left ventricular enlargement, LVEF=0.40, blood pressure = 110/90mmHg for 1 week before inclusion, diuretic resistance ?5 days; 3. Patients with dilated cardiomyopathy had heart failure with enlarged left or whole heart, LVEF=0.40, duration of heart failure = 1 month, blood pressure = 110/90mmHg, diuretic resistance = 5 days; 4. Patients with hypertrophic cardiomyopathy had heart failure, left heart or whole heart enlargement, LVEF=0.40 with or without ventricular septal or other ventricular wall hypertrophy, blood pressure = 110/90mmHg for 1 week, heart failure duration ?1 month, diuretic resistance ?5 days; 5. In patients with valvular heart disease, LVEF is not limited, the duration of heart failure and fluid retention ?1 month, blood pressure = 110/90mmHg, diuretic resistance ?5 days.

Exclusion criteria

Exclusion criteria: 1. Rule out new heart failure in acute coronary syndrome; 2. Hypertension (?140/90mmHg) accompanied by heart failure was excluded; 3. Hypertrophic cardiomyopathy with LVEF = 0.41 or heart failure with normal ejection fraction were excluded; 4. New heart failure caused by acute myocarditis was excluded; 5. Rule out heart failure caused by acute injury of heart (myocardium) and mechanical complications of heart; 6. Rule out heart failure caused by thyroid, pituitary and adrenal diseases; Insulin assisted in diabetic patients; 7. Exclude heart failure caused by primary liver failure, primary kidney failure, heart-kidney syndrome or severe heart failure with abnormal liver enzymes (heart-liver syndrome) should be = 10-20 times the normal upper limit; 8. Rule out fever, systemic or local bacterial or viral infections; 9. Rule out heart failure during pregnancy and childbirth. 10. All the above patients are allergic to glucocorticoid or methylprednisolone sodium succinate.

Design outcomes

Primary

MeasureTime frame
Spot urinary sodium concentration;Mortality at 6 months;Hemoglobin;6 months heart failure readmitted;

Secondary

MeasureTime frame
Weight;Estimated glomerular filtration rate(eGFR);Heart rate;Blood pressure;Serum creatinine;Serum urea nitrogen;Serum B-type natriuretic peptide;Serum uric acid;Blood glucose level;Blood lipid level;Decongestion effects;Hepatic function;Blood lipid;Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactLiu Chao

The First Hospital of Hebei Medical University

dr.liuchao@hotmail.com+86 186 3388 9667

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026