Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

Last updated: February 20, 2025
Sponsor: 35Pharma Inc
Overall Status: Active - Recruiting

Phase

1

Condition

Chest Pain

Heart Disease

Stress

Treatment

HS135

Placebo

Clinical Study ID

NCT06581159
HS135-003
  • Ages > 18
  • All Genders

Study Summary

A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

Eligibility Criteria

Inclusion

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 daysbefore Screening.

  3. Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) atleast 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 allprotocol requirements.

Exclusion

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, orcardiac surgery within 30 days prior to Screening.

  3. Implantation of cardiac resynchronization therapy (CRT) device within 90 days priorto Screening.

  4. Planned cardiovascular revascularization or major cardiac surgery or plannedimplantation 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 inthe 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 inthe opinion of the investigator increases the risk of participating in the study.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: HS135
Phase: 1
Study Start date:
January 23, 2025
Estimated Completion Date:
June 30, 2027

Study Description

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

Connect with a study center

  • Site-104

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Site-105

    Kansas City, Missouri 64111
    United States

    Site Not Available

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