A Trial to Study BAY1753011 in Patients With Congestive Heart Failure (NCT03901729) | Clinical Trial Compass
CompletedPhase 2
A Trial to Study BAY1753011 in Patients With Congestive Heart Failure
Austria482 participantsStarted 2019-05-29
Plain-language summary
To assess the efficacy of 30 mg of BAY1753011, with or without furosemide, versus furosemide alone in patients with heart failure and objective evidence of congestion.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History of CHF on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks prior to index hospitalization and in accordance with international guidelines.
* Subjects admitted to the hospital with a primary diagnosis of decompensated HF including symptoms and signs of fluid overload requiring IV diuretic therapy in the Emergency room (ER) or any time between day 1-3 of hospital admission (index hospitalization).
* Subjects on an average/usual total daily dose of loop diuretic ≥ 40 mg of furosemide or equivalent, within 4 weeks prior to index hospitalization.
* At least one of the following 5 parameters any day between 3-7 of index hospitalization (screening period)
* Natriuretic peptides Brain natriuretic peptide/N-terminal prohormone of brain natriuretic peptide (BNP/NT-proBNP):
* Drop in BNP or NT-proBNP ≤ 30% from admission values (if measured during index hospitalization) or
* BNP ≥ 500 pg/ml or NT-proBNP ≥ 1800 pg/ml at screening (day 3 to 7 of index hospitalization)
* Body weight (BW) loss \<0.4 kg per 40 mg furosemide at day 4 of index hospitalization
* Composite congestion score (CCS) ≥ 3
* Hypervolemic hyponatremia defined as serum sodium \< 136 mmol/l
* In hospital worsening renal function defined as increased serum creatinine ≥ 0.3 mg/dl compared to index hospitalization admission values AND at least one the following
* Jugular venous pressure (JVP) ≥ 10 cm on …
What they're measuring
1
PART A: Change in body weight
Timeframe: Compare Day 30 (End of part A) with Day 1 (Start of part A)
2
PART A: Change in serum creatinine
Timeframe: Compare Day 30 (End of part A) with Day 1 (Start of part A)
3
PART B: Change in body weight
Timeframe: Compare Day 60 (End of part B) with Day 30 (Start of part B)
4
PART B: Change in log transformed blood urea nitrogen (BUN)/creatinine ratio
Timeframe: Compare Day 60 (End of part B) with Day 30 (Start of part B)