RENEU-PHJK07 for Heart Failure with Pulmonary Hypertension
The study aims to evaluate the effectiveness of JK07 as a treatment for heart failure in patients who also have pulmonary hypertension.
JK07
Cardiovascular Diseases+7
+ Heart Diseases
+ Heart Failure
Treatment Study
Summary
Study start date: December 15, 2025
Actual date on which the first participant was enrolled.This clinical trial is designed to explore the safety, how well people can tolerate, and the effectiveness of a new treatment called JK07 for adults who are 18 to 85 years old and have heart failure along with a specific type of high blood pressure in the lungs, known as combined post-capillary and pre-capillary pulmonary hypertension (cpcPH). This study aims to address the need for effective treatments for these individuals, as managing heart failure with associated lung pressure issues can be challenging. Participants in this study will receive multiple high doses of JK07, which is part of an open-label trial, meaning both the researchers and participants will know the treatment being given. This study will enroll at least 20, and possibly up to 30, participants. The trial will primarily focus on evaluating how safe and tolerable the medication is, alongside observing any potential benefits in treating the condition. The study does not specify particular outcomes but aims to gather valuable information on the effects of JK07 in this patient group.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Key Inclusion Criteria: * Participants with HF New York Heart Association Class II-III. * Participants will be classified as having HFrEF (LVEF ≤ 40%) or HFpEF (LVEF \>40% and ≤70%). * Right heart catheterization (RHC) based evidence of cpcPH: * PVR ≥2.5 WU; AND * mPAP ≥25 mmHg; AND * PAWP ≥16 mmHg Key Exclusion Criteria: * Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5. * Contraindicated to RHC that can be left in place for approximately 6 hours. * A diagnosis of pre-existing lung disease including congenital abnormalities, full or partial pneumonectomy, or previous therapeutic radiation of lungs or mediastinum. * Body mass index (BMI) \>45 kg/m² at screening.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Saint Francis Heart and Vascular Institute
Tulsa, United StatesOpen Saint Francis Heart and Vascular Institute in Google Maps