Treatment of Obese Patients with Pulmonary Hypertension and Heart Failure

Phase 1b Double-Blind, Placebo-Controlled, MAD Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

This study is testing a new treatment called HS135 to see if it can help obese patients with pulmonary hypertension and heart failure feel better and improve their health.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: 35Pharma Inc (Industry-sponsored)
• Locations: 2 sites (Phoenix, Arizona and 1 other locations)
• Trial ID: NCT06581159 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of HS135 in obese patients suffering from pulmonary hypertension and heart failure with preserved ejection fraction (HFpEF). It is a Phase 1b, multicenter, double-blind, placebo-controlled trial that will assess the pharmacokinetics and pharmacodynamics of HS135 through multiple ascending doses. Participants will be monitored for their heart failure symptoms and overall health outcomes throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are obese adults over 18 years old with a diagnosis of HFpEF and specific heart failure symptoms.

Not a fit: Patients with decompensated heart failure or recent cardiac interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve heart function and quality of life for obese patients with pulmonary hypertension and HFpEF.

How similar studies have performed: While there have been studies on heart failure treatments, this specific approach using HS135 in this patient population is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

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

1. Male or female, \>18 years of age.
2. CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
3. Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
4. New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
5. BMI ≥ 30 kg/m2.
6. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

1. Decompensated heart failure.
2. Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
3. Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
4. Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
5. History of heart transplant or on heart transplant list.
6. Uncontrolled systemic hypertension.
7. Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.
8. Patients who have full pneumonectomy or a severe chronic pulmonary disorder that in the opinion of the investigator increases the risk of participating in the study.

Where this trial is running

Phoenix, Arizona and 1 other locations

• Site-104 — Phoenix, Arizona, United States (Recruiting)
• Site-105 — Kansas City, Missouri, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Roxanne Julien, M.Sc.

Conditions Heart Failure With Preserved Ejection Fraction; Pulmonary Hypertension