Heart Failure With Volume Overload
Conditions
Brief summary
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.
Interventions
DRUGHRS-9057
HRS-9057 injection dose 1
DRUGTolvaptan
Tolvaptan tablets
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HRS-9057 injection was compared with Tolvaptan tablets
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, age 18-75 years at the time of signing informed consent. 2. Diagnosed as chronic heart failure at least 1 month prior to screening. 3. Patients with CHF in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment.
Exclusion criteria
1. Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening; 2. Hypovolemic hyponatremia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of any adverse events (AEs) | baseline up to Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax for HRS-9057 | Predose on Day 1 through Day 6 | — |
| Daily urine volume | Predose on Day 1 through Day 7 | — |
| Daily fluid balance | Predose on Day 1 through Day 7 | Daily fluid balance is calculated by subtracting daily urine volume from daily fluid intake. |
| Serum sodium concentration | Predose on Day 1 through Day 6 | — |
| Serum osmolality | Predose on Day 1 through Day 6 | — |
| Tmax for HRS-9057 | Predose on Day 1 through Day 6 | — |
| Body weight | baseline to Day 8 | — |
| Lower limb edema change from baseline | baseline to Day 8 | The severity of edema in the subject's tibial border or dorsum of the foot will be assessed in the sitting position using a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe) by the investigator. The percentage of subjects in whom the lower limb edema was improved or worsening at Day 8 will be evaluated. |
| Jugular venous distension change from baseline | baseline to Day 8 | Whether or not the subject has jugular venous distension will be documented. If distension is observed, the vertical height (in centimeters) from the sternal angle to the highest point of pulsation of the internal jugular vein will be documented and the change from baseline to Day 8 will be evaluated. |
| Pulmonary congestion change from baseline | baseline to Day 8 | The investigator will perform chest X-ray at baseline and Day 8 to assess the severity of pulmonary congestion using a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). The percentage of subjects in whom pulmonary congestion was improved or worsening at Day 8 will be evaluated. |
| New York Heart Association (NYHA) classification change from baseline | baseline to Day 8 | — |
| Urine osmolality | Predose on Day 1 through Day 7 | — |
Countries
China
Outcome results
None listed