A Study of HRS-9057 in Patients With Heart Failure and Volume Overload

Phase 1

Not yet recruiting

• Conditions: Heart Failure With Volume Overload
• Interventions: Drug: HRS-9057; Drug: Tolvaptan

• Registration Number: NCT06506994
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-28
• Study Start: 2024-07-15
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Primary Completion: 2024-09-20
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Male or female, age 18-70 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A: HRS-9057/ Tolvaptan	HRS-9057	-
Treatment group B: HRS-9057/ Tolvaptan	HRS-9057	-
Treatment group A: HRS-9057/ Tolvaptan	Tolvaptan	-
Treatment group B: HRS-9057/ Tolvaptan	Tolvaptan	-

Primary Outcome Measures

Name	Time	Method
The incidence and severity of any adverse events (AEs)	baseline up to Day 14

Secondary Outcome Measures

Name	Time	Method
Cmax for HRS-9057	Predose on Day 1 through Day 6
Serum osmolality	Predose on Day 1 through Day 6
Urine osmolality	Predose on Day 1 through Day 7
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.
Tmax for HRS-9057	Predose on Day 1 through Day 6
Serum sodium concentration	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.
Body weight	baseline to Day 8
New York Heart Association (NYHA) classification change from baseline	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.
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.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China