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Not yet recruiting NCT07123779

Study of HS235 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF)

Phase I Interventional Pulmonary Hypertension Heart Failure With Preserved Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS235, Placebo.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase Ib, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Patients With Pulmonary Hypertension and HFpEF

Overview

Study of HS235 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction Utilizing Ambulatory Pulmonary Artery Pressure Monitoring

Detailed description

A Phase Ib, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction Utilizing Ambulatory Pulmonary Artery Pressure Monitoring

Interventions

  • Biological HS235
    Subcutaneous Injection
  • Other Placebo
    Subcutaneous Injection

Primary outcome measures

  • Incidence and Number of Adverse Events (AEs) [Time frame: Up to 24 weeks]

Eligibility criteria

Inclusion criteria

Patients are eligible to be included in the study only if they meet at least all the following criteria:

  • Male or female, ≥ 18 years of age.
  • Ambulatory pulmonary artery pressure (PAP) monitoring (e.g. CardioMEMS™ HF System or Cordella™ HF System) implanted in the course of standard of care at least 90 days before Screening with mean pulmonary artery pressure (mPAP) ≥ 25 mmHg and diastolic pulmonary artery pressure(dPAP) ≥ 15 mmHg as averaged over the last 2 weeks prior to Randomization.
  • Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 % as measured by echocardiography during Screening.
  • New York Heart Association (NYHA) class II or III heart failure symptoms.
  • Stable diuretic regimen during the screening period.
  • Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) < 90 at screening.
  • 6-minute walking distance (6MWD) ≥ 100 m at screening.
  • Body mass index ≥ 30 to ≤ 50 kg/m2 and Body weight ≤140 kg.
  • Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

Exclusion criteria

  • Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
  • Occurrence of an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 90 days prior to Screening.
  • Implantation of a cardiac resynchronization therapy (CRT) device within 90 days before screening.
  • Planned cardiovascular revascularization or planned implantation of CRT device.
  • History of heart transplant or on heart transplant list.
  • History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening.
  • Systemic hypotension or uncontrolled systemic hypertension.
  • History of Pericardial constriction or hypertrophic cardiomyopathy.
  • History of significant valvular stenosis or regurgitation.
  • Patients with a pneumonectomy or more than moderate Chronic Obstructive Pulmonary Disease (COPD) or mild interstitial lung disease (ILD) or mild obstructive sleep apnea (OSA).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07123779 · HS235-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗