TERMINATED

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

Conditions

Heart Failure With Preserved Ejection Fraction Pulmonary Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-23

Study Completion:2025-07-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06581159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Monique Champagne, M.Sc.

STUDY_DIRECTOR

35Pharma Inc

Study Locations (Sites)

Site-104

Phoenix, Arizona, 85016

United States

Site-105

Kansas City, Missouri, 64111

United States

Collaborators and Investigators

Sponsor: 35Pharma Inc

Monique Champagne, M.Sc., STUDY_DIRECTOR, 35Pharma Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-23

Study Completion Date2025-07-29

Study Record Updates

Study Start Date2025-01-23

Study Completion Date2025-07-29

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension