Heart Failure With Preserved Ejection FractionPhase 1NCT06581159
Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
A Phase 1 study testing HS135 in people with Heart Failure With Preserved Ejection Fraction and Pulmonary Hypertension, run by 35Pharma Inc., a GSK company at 2 sites in United States.
Trial summary
A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Pulmonary Hypertension
- What is being tested?
- HS135
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2025to 29 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
- Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
- New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
- BMI ≥ 30 kg/m2.
- Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- Decompensated heart failure.
- Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
- Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
- Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
- History of heart transplant or on heart transplant list.
Show all 9Show fewer
- Uncontrolled systemic hypertension.
- Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site-105
Kansas City, Missouri, 64111
Site-104
Phoenix, Arizona, 85016
About this study
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
A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Read the detailed 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
- Being tested
- HS135, Placebo
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS135Biological
Subcutaneous Injection
PlaceboOther
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | HS135 Subcutaneous Injection Receives: Biological: HS135 |
| Placebo | Placebo comparator | Subcutaneous Injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Number of Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of patients who experience an AE will be reported.
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): White Blood Cell Count
Blood samples will be collected to determine the White Blood Cell Count at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Platelet Count
Blood samples will be collected to determine the Platelet Count at designated time points up to 24 weeks.
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Red Blood Cell Count
Blood samples will be collected to determine the Red Blood Cell Count at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Hemoglobin
Blood samples will be collected to determine concentration of Hemoglobin at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Hematocrit
Blood samples will be collected to determine concentration of Hematocrit at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Albumin
Blood samples will be collected to determine concentration of Albumin at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Aspartate aminotransferase (AST)
Blood samples will be collected to determine concentration of AST designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alanine aminotransferase (ALT)
Blood samples will be collected to determine concentration of ALT designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alkaline phosphatase (ALP)
Blood samples will be collected to determine concentration of ALP designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Bilirubin
Blood samples will be collected to determine concentration of Total Bilirubin at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Calcium
Blood samples will be collected to determine concentration of Calcium at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Creatinine
Blood samples will be collected to determine concentration of Creatinine at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Glucose
Blood samples will be collected to determine concentration of Glucose at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Urea
Blood samples will be collected to determine concentration of Urea at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Cholesterol
Blood samples will be collected to determine concentration of Total Cholesterol at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): High-density Lipoprotein-cholesterol (HDL-c)
Blood samples will be collected to determine concentration of HDL-c at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Low-density Lipoprotein-cholesterol (LDL-c)
Blood samples will be collected to determine concentration of LDL-c at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Chloride
Blood samples will be collected to determine concentration of Chloride at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Potassium
Blood samples will be collected to determine concentration of Potassium at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Sodium
Blood samples will be collected to determine concentration of Sodium at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Blood (occult)
Urine samples will be collected to determine the presence of Blood (occult) at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Ketones
Urine samples will be collected to determine the presence of Ketones at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Leukocyte Esterase
Urine samples will be collected to determine the presence Leukocyte Esterase of at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Nitrites
Urine samples will be collected to determine the presence of Nitrites at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Bilirubin
Urine samples will be collected to determine the presence of Bilirubin at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Glucose
Urine samples will be collected to determine the presence of Glucose at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Urobilinogen
Urine samples will be collected to determine concentration of Urobilinogen at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Protein
Urine samples will be collected to determine the presence of Protein at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): pH
Urine samples will be collected to determine the pH at designated time points up to 24 weeks
Measured: Up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Specific Gravity
Urine samples will be collected to determine the Specific Gravity at designated time points up to 24 weeks
Measured: Up to 24 weeks
Secondary outcomes (8)
Change from Baseline in mean pulmonary artery diastolic pressure (mPADP) at designated time points up to 24 weeks
To determine mean pulmonary artery diastolic pressure (mPADP)
Measured: Up to 24 weeks
Change from Baseline in mean pulmonary artery pressure (mPAP) at designated time points up to 24 weeks
To determine mean pulmonary artery pressure (mPAP)
Measured: Up to 24 weeks
Change from Baseline in mean pulmonary artery systolic pressure (mPASP) at designated time points up to 24 weeks
To determine mean pulmonary artery systolic pressure (mPASP)
Measured: Up to 24 weeks
Change in New York Heart Association (NYHA) Class at designated time points up to 24 weeks
To determine change in New York Heart Association (NYHA) Class at Week 24
Measured: Up to 24 weeks
Change from Baseline in number of hospitalizations or urgent outpatient visits for heart failure during the treatment period at designated time points at designated time points up to 24 weeks
To determine number of hospitalizations or urgent outpatient visits for heart failure during the treatment period
Measured: Up to 24 weeks
Change from Baseline to Week 24 in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at designated time points up to 24 weeks
To determine N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Measured: Up to 24 weeks
Change from Baseline in 6-minute walk distance (6MWD) at designated time points up to 24 weeks
To determine 6-minute walk distance (6MWD)
Measured: Up to 24 weeks
Change from Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CS) and Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS) at designated time points up to 24 weeks
To determine change from Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CS) and Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS) at Week 24.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start23 Jan 2025
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it stopped: Sponsor's Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- 35Pharma Inc., a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monique Champagne, M.Sc., Study director, 35Pharma Inc., a GSK company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581159
- Sponsor's protocol ID
- HS135-003
- Status last verified
- Jul 2025
- First submitted
- 9 Aug 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06581159
- Acronym / sponsor ID
- HS135-003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's Decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- 35Pharma Inc., a GSK companyIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Biological: HS135HS135 Subcutaneous Injection |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
- Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
- New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
Key exclusion criteria (9 listed)
- Decompensated heart failure.
- Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
- Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
- Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
- History of heart transplant or on heart transplant list.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS135Subcutaneous Injection | Biological | Investigational Product |
| PlaceboSubcutaneous Injection | Other | Placebo |
Primary outcome
Incidence and Number of Adverse Events (AEs)
Time frame: Up to 24 weeks
An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of patients who experience an AE will be reported.
Change from Baseline in Clinical Laboratory Parameters (Hematology): White Blood Cell Count
Time frame: Up to 24 weeks
Blood samples will be collected to determine the White Blood Cell Count at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Platelet Count
Time frame: Up to 24 weeks
Blood samples will be collected to determine the Platelet Count at designated time points up to 24 weeks.
Change from Baseline in Clinical Laboratory Parameters (Hematology): Red Blood Cell Count
Time frame: Up to 24 weeks
Blood samples will be collected to determine the Red Blood Cell Count at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Hemoglobin
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Hemoglobin at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Hematology): Hematocrit
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Hematocrit at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Albumin
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Albumin at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Aspartate aminotransferase (AST)
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of AST designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alanine aminotransferase (ALT)
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of ALT designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alkaline phosphatase (ALP)
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of ALP designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Bilirubin
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Total Bilirubin at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Calcium
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Calcium at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Creatinine
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Creatinine at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Glucose
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Glucose at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Urea
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Urea at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Total Cholesterol
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Total Cholesterol at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): High-density Lipoprotein-cholesterol (HDL-c)
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of HDL-c at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Low-density Lipoprotein-cholesterol (LDL-c)
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of LDL-c at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Chloride
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Chloride at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Potassium
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Potassium at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Sodium
Time frame: Up to 24 weeks
Blood samples will be collected to determine concentration of Sodium at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Blood (occult)
Time frame: Up to 24 weeks
Urine samples will be collected to determine the presence of Blood (occult) at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Ketones
Time frame: Up to 24 weeks
Urine samples will be collected to determine the presence of Ketones at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Leukocyte Esterase
Time frame: Up to 24 weeks
Urine samples will be collected to determine the presence Leukocyte Esterase of at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Nitrites
Time frame: Up to 24 weeks
Urine samples will be collected to determine the presence of Nitrites at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Bilirubin
Time frame: Up to 24 weeks
Urine samples will be collected to determine the presence of Bilirubin at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Glucose
Time frame: Up to 24 weeks
Urine samples will be collected to determine the presence of Glucose at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Urobilinogen
Time frame: Up to 24 weeks
Urine samples will be collected to determine concentration of Urobilinogen at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Protein
Time frame: Up to 24 weeks
Urine samples will be collected to determine the presence of Protein at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): pH
Time frame: Up to 24 weeks
Urine samples will be collected to determine the pH at designated time points up to 24 weeks
Change from Baseline in Clinical Laboratory Parameters (Urinalysis): Specific Gravity
Time frame: Up to 24 weeks
Urine samples will be collected to determine the Specific Gravity at designated time points up to 24 weeks
8 secondary outcomes
Change from Baseline in mean pulmonary artery diastolic pressure (mPADP) at designated time points up to 24 weeks
Time frame: Up to 24 weeks
Change from Baseline in mean pulmonary artery pressure (mPAP) at designated time points up to 24 weeks
Time frame: Up to 24 weeks
Change from Baseline in mean pulmonary artery systolic pressure (mPASP) at designated time points up to 24 weeks
Time frame: Up to 24 weeks
Change in New York Heart Association (NYHA) Class at designated time points up to 24 weeks
Time frame: Up to 24 weeks
Change from Baseline in number of hospitalizations or urgent outpatient visits for heart failure during the treatment period at designated time points at designated time points up to 24 weeks
Time frame: Up to 24 weeks
Change from Baseline to Week 24 in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at designated time points up to 24 weeks
Time frame: Up to 24 weeks
Change from Baseline in 6-minute walk distance (6MWD) at designated time points up to 24 weeks
Time frame: Up to 24 weeks
Change from Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CS) and Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS) at designated time points up to 24 weeks
Time frame: Up to 24 weeks
Results and safety
The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Related trials for Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique Champagne, M.Sc. study director
35Pharma Inc., a GSK company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS135 in people with Heart Failure With Preserved Ejection Fraction and Pulmonary Hypertension, run by 35Pharma Inc., a GSK company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Number of Adverse Events (AEs) (time frame: Up to 24 weeks). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.