Heart Failure With Preserved Ejection FractionPhase 2CAPACITY-HFpEFNCT03254485

A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

A Phase 2 study testing IW-1973 in people with Heart Failure With Preserved Ejection Fraction, run by Akebia Therapeutics at 62 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Heart Failure With Preserved Ejection Fraction
What is being tested?: IW-1973
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 196 participants
Where: 62 sitesin 2 countries
Study dates: 7 Nov 2017to 19 Aug 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is an ambulatory male or female ≥45 years old at the Screening Visit
Patient has heart failure with ejection fraction (EF) of ≥40%
Patient has a peak VO2 measuring <80% of age- and sex-adjusted normal values
Patient has evidence in medical history supporting clinical heart failure syndrome consisting of at least 1 of the following:
Hospitalization or emergency department visit for heart failure within the past year
Elevated B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) within the past 6 months

Show all 13Show fewer

Echocardiographic evidence within the past 12 months of at least 2 of the following: left ventricular (LV) hypertrophy, left atrial (LA) enlargement, or diastolic dysfunction
Hemodynamic evidence of elevated filling pressures
Patient meets at least 2 of the following criteria at the Screening Visit:
Diagnosis of type 2 diabetes mellitus or prediabetes
History of hypertension
Body mass index (BMI) >30 kg/m2
Age ≥70 years

Who cannot join

Patient has had acute coronary syndrome or percutaneous coronary intervention within 30 days before Randomization
Patient has had cardiac transplantation or has cardiac transplantation planned during the study
Patient has had cardiac artery bypass graft, cardiac mechanical support implantation, or other cardiac surgery in the 3 months before the Screening Visit or planned during the study
Patient has severe chronic obstructive coronary disease as defined by chronic oxygen dependence
Patient had had heart failure hospitalization with discharge within 30 days before the Screening Visit
Patient has a history of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products

Show all 12Show fewer

Patient has previously received IW-1973 in a study, or received an investigational drug during the 30 days or 5 half lives of that investigational drug (whichever is longer) before the Screening Visit, or is planning to receive another investigational drug at any time during the study
Patient is taking specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of PDE5, any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide (NO) donors in any form
Patient is taking strong cytochrome P450 3A (CYP3A) inhibitors
Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug
Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug
Other exclusion criteria per protocol

Trial locations and contacts

62 sites in 2 countries.

Country

City, postcode or hospital

62 sites in 2 countries

United States57 sites

Lousiana Heart Center
Bogalusa, Louisiana, 70427
St. Luke's Regional Medical Center
Boise, Idaho, 83712
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University School of Medicine
Boston, Massachusetts, 02118
Lahey Clinic
Burlington, Massachusetts, 01805
University of Vermont Medical Center
Burlington, Vermont, 05401
Northwestern University
Chicago, Illinois, 60611
Ohio State University Medical Center (OSUMC)
Columbus, Ohio, 43210
North Dallas Research Associates
Dallas, Texas, 75069
Texas Health Research and Education Insitute
Dallas, Texas, 75231
Southwest Family Medicine Associates
Dallas, Texas, 75235
Baylor University Medical Center
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Aurora Denver Cardiology
Denver, Colorado, 80218
Duke University Medical Center
Durham, North Carolina, 27710
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
New Generation of Medical Research
Hialeah, Florida, 33016
Franciscan Physician Network - Indiana Heart Physicians
Indianapolis, Indiana, 46237
East Coast Institute for Research
Jacksonville, Florida, 32216
University of Kansas Medical Center
Kansas City, Kansas, 66160
JEHM
La Mesa, California, 91941
Research Institute of Lancaster General Health
Lancaster, Pennsylvania, 17602
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204
South Denver Cardiology Associates
Littleton, Colorado, 80120
Axis Clinical Trials
Los Angeles, California, 90036
Unity Point Health
Madison, Wisconsin, 53713
University of Wisconsin - Madison
Madison, Wisconsin, 53792
PCRS Network, LLC
Miami, Florida, 33126
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
JEHM
National City, California, 91950
Mount Sinai School of Medicine
New York, New York, 10025
Valley Clinical Trials
Northridge, California, 91325
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135
Newton Clinical Research
Oklahoma City, Oklahoma, 73159
Stanford University
Palo Alto, California, 94305
Broward Research Center
Pembroke Pines, Florida, 33024
Unity Point Health - Methodist Hospital
Peoria, Illinois, 61602
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Arizona Arrhythmia Research Center
Phoenix, Arizona, 85016
Progressive Medical Research
Port Orange, Florida, 32127
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, 23298
The Valley Hospital
Ridgewood, New Jersey, 07450
Mayo Clinic
Rochester, Minnesota, 55905
Schnitzler Cardiovascular Consultants
San Antonio, Texas, 78229
Mayo Clinic
Scottsdale, Arizona, 85259
PeaceHealth, Sacred Heart Physicians
Springfield, Oregon, 97477
VA Healthcare John Cochran Medical Center
St Louis, Missouri, 63106
Washington University
St Louis, Missouri, 63110
Madigan Army Medical Center
Tacoma, Washington, 98431
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Harbor UCLA Medical Center
Torrance, California, 90509
University of Arizona
Tucson, Arizona, 85724
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Michigan Heart
Ypsilanti, Michigan, 48197

Other trials in United States

Canada5 sites

Ecogene-21
Chicoutimi, Quebec, G7H 7K9
London Health Sciences Centre
London, Ontario, N6A 5A5
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, G1V 4G5
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1G 2E8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 Over 12 Weeks in Patients With Heart Failure With Preserved Ejection Fraction

The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.

Conditions: Heart Failure With Preserved Ejection Fraction
Being tested: IW-1973, Placebo Oral Tablet
Keywords: Heart Failure, Cardiovascular, HF, HFpEF
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IW-1973Drug
Oral Tablet
Placebo Oral TabletDrug
Oral Tablet

Study groups in NCT03254485
Study group	Role	What they receive
IW-1973 High Dose	Experimental	Not described Receives: Drug: IW-1973
Placebo	Placebo comparator	Placebo to match experimental drug Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Study Drug-related TEAEs
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those adverse events (AEs) that started or worsened in severity after the administration of study drug. Causality relationship to study drug was per Investigator assessment. Number of participants with TEAEs and study drug-related TEAEs is presented.
Measured: Day 1 up to Day 113
Change From Baseline in Peak Oxygen Consumption (VO2) at Week 12
Peak VO2 was obtained from Cardiopulmonary Exercise Test (CPET), which was used to evaluate the effect of praliciguat on peak exercise capacity. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an analysis of covariance (ANCOVA) model with treatment group and atrial fibrillation stratification factors as categorical variable terms and Baseline peak VO2 value as a covariate. Milliliter O2 per kilogram per minute = mL O2/kg/min
Measured: Baseline and Week 12

Secondary outcomes (3)

Change From Baseline in 6-minute Walk Test (6MWT) Distance at Week 12
6MWT was a simple assessment of everyday functional capacity and provided a global evaluation of the organ/physiologic systems involved in exercise. 6MWT assessed the distance travelled in 6 minutes, measured at approximately the same time of day. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an ANCOVA model with treatment group, atrial fibrillation stratification factor and peak VO2 stratification factor as categorical variable terms and Baseline value as a covariate.
Measured: Baseline and Week 12
Change From Baseline in Ventilatory Efficiency at Week 12
Ventilatory efficiency was defined as minute ventilation/carbon dioxide (VE/VCO2) slope, production and was obtained from CPET. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an ANCOVA model with treatment group, atrial fibrillation stratification factor and peak VO2 stratification factor as categorical variable terms and baseline value as a covariate.
Measured: Baseline and Week 12
CPET Responders at Week 12
CPET responders were defined as participants who improved by at least 1.5 mL O2/kg/min in peak VO2 from Baseline to Week 12. Baseline is defined as the last non-missing measurement prior to the first dose of study drug.
Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 201719 Aug 2019

First posted18 Aug 2017
Study start7 Nov 2017
Primary completion19 Aug 2019
Study completion19 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03254485
Sponsor's protocol ID: C1973-204
Acronym: CAPACITY-HFpEF
Status last verified: Aug 2022
First submitted: 16 Aug 2017
Last updated: 15 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Udelson JE, Lewis GD, Shah SJ, Zile MR, Redfield MM, Burnett J Jr, Parker J, Seferovic JP, Wilson P, Mittleman RS, Profy AT, Konstam MA. Effect of Praliciguat on Peak Rate of Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: The CAPACITY HFpEF Randomized Clinical Trial. JAMA. 2020 Oct 20;324(15):1522-1531. doi: 10.1001/jama.2020.16641.
PubMed 33079154
Udelson JE, Lewis GD, Shah SJ, Zile MR, Redfield MM, Burnett J Jr, Mittleman RS, Profy AT, Seferovic JP, Reasner D, Konstam MA. Rationale and design for a multicenter, randomized, double-blind, placebo-controlled, phase 2 study evaluating the safety and efficacy of the soluble guanylate cyclase stimulator praliciguat over 12 weeks in patients with heart failure with preserved ejection fraction (CAPACITY HFpEF). Am Heart J. 2020 Apr;222:183-190. doi: 10.1016/j.ahj.2020.01.009. Epub 2020 Jan 21.
PubMed 32105984

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Heart Failure With Preserved Ejection Fraction trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 Over 12 Weeks in Patients With Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT03254485
Acronym / sponsor ID: CAPACITY-HFpEF / C1973-204
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: Heart Failure, Cardiovascular, HF, HFpEF
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Akebia TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: Cyclerion Therapeutics
Study start: 7 Nov 2017 (actual)
Primary completion: 19 Aug 2019 (actual)
Study completion: 19 Aug 2019 (actual)
First posted: 18 Aug 2017 (actual)
Results: Posted 15 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IW-1973 High Dose	Experimental	Drug: IW-1973
Placebo	Placebo comparator	Drug: Placebo Oral TabletPlacebo to match experimental drug

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Patient is an ambulatory male or female ≥45 years old at the Screening Visit
Patient has heart failure with ejection fraction (EF) of ≥40%
Patient has a peak VO2 measuring <80% of age- and sex-adjusted normal values
Patient has evidence in medical history supporting clinical heart failure syndrome consisting of at least 1 of the following:
Patient meets at least 2 of the following criteria at the Screening Visit:

Key exclusion criteria (12 listed)

Patient has had acute coronary syndrome or percutaneous coronary intervention within 30 days before Randomization
Patient has had cardiac transplantation or has cardiac transplantation planned during the study
Patient has had cardiac artery bypass graft, cardiac mechanical support implantation, or other cardiac surgery in the 3 months before the Screening Visit or planned during the study
Patient has severe chronic obstructive coronary disease as defined by chronic oxygen dependence
Patient had had heart failure hospitalization with discharge within 30 days before the Screening Visit

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
IW-1973Oral Tablet	Drug	IW-1973 High Dose
Placebo Oral TabletOral Tablet	Drug	Placebo

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Study Drug-related TEAEs
Time frame: Day 1 up to Day 113
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those adverse events (AEs) that started or worsened in severity after the administration of study drug. Causality relationship to study drug was per Investigator assessment. Number of participants with TEAEs and study drug-related TEAEs is presented.
Change From Baseline in Peak Oxygen Consumption (VO2) at Week 12
Time frame: Baseline and Week 12
Peak VO2 was obtained from Cardiopulmonary Exercise Test (CPET), which was used to evaluate the effect of praliciguat on peak exercise capacity. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an analysis of covariance (ANCOVA) model with treatment group and atrial fibrillation stratification factors as categorical variable terms and Baseline peak VO2 value as a covariate. Milliliter O2 per kilogram per minute = mL O2/kg/min

3 secondary outcomes

Change From Baseline in 6-minute Walk Test (6MWT) Distance at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Ventilatory Efficiency at Week 12
Time frame: Baseline and Week 12
CPET Responders at Week 12
Time frame: At Week 12

Results and safety

Results posted to the registry on 15 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	90	78
Praliciguat 10 mg	7	7
Praliciguat 20 mg	7	7
Praliciguat 40 mg	92	77

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Study Drug-related TEAEs

Time frame: Day 1 up to Day 113. Count of participants. Unit: Participants

Measure	Placebo n = 90	Praliciguat 10 mg n = 7	Praliciguat 20 mg n = 7	Praliciguat 40 mg n = 91
TEAEs	61	4	6	72
Study drug-related TEAEs	9	1	0	22

Population analysed: Safety Population consisted of all randomized participants who took at least 1 dose of study drug.

Primary outcome: Change From Baseline in Peak Oxygen Consumption (VO2) at Week 12

Time frame: Baseline and Week 12. Least squares mean (95% Confidence Interval). Unit: mL O2/kg/min

Measure	Placebo n = 72	Praliciguat 40 mg n = 64
Value	0.04 (-0.49 to 0.56)	-0.26 (-0.83 to 0.31)

Placebo vs Praliciguat 40 mg: Least Squares Mean Difference: -0.30 (95% CI -0.95 to 0.35), p =0.3681, ANCOVA

Population analysed: Evaluable Population consisted of all participants in the modified (m)ITT population who completed 8 weeks of dosing (±3 days) and had at least 1 evaluable post-Baseline assessment and did not have a dose reduction. Only those participants with data available at the specified data points were analyzed. Following protocol amendment 3, efficacy analyses included only the praliciguat 40 mg and placebo groups; the praliciguat 10 mg and 20 mg groups were excluded from all efficacy analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug (Day 1) up to Follow-up Visit (Day 113). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	9 of 90 (10%)	58 of 90 (64.4%)	0 of 90
Praliciguat 10 mg	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Praliciguat 20 mg	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
Praliciguat 40 mg	10 of 91 (11%)	68 of 91 (74.7%)	1 of 91

Limitations and caveats (from the sponsor): Due to changes in study objectives and design (protocol amendment 3), all efficacy analyses was performed using only the praliciguat 40 mg and placebo groups; the praliciguat 10 mg and 20 mg groups were excluded from all efficacy analysis. For completeness, participants treated with both 10 mg and 20 mg praliciguat are included in the AE summaries for safety analyses, as well as for Participant Flow and Baseline Characteristics.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33079154Udelson JE, Lewis GD, Shah SJ, Zile MR, Redfield MM, Burnett J Jr, Parker J, Seferovic JP, Wilson P, Mittleman RS, Profy AT, Konstam MA. Effect of Praliciguat on Peak Rate of Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: The CAPACITY HFpEF Randomized Clinical Trial. JAMA. 2020 Oct 20;324(15):1522-1531. doi: 10.1001/jama.2020.16641.
Derived from this study: PubMed 32105984Udelson JE, Lewis GD, Shah SJ, Zile MR, Redfield MM, Burnett J Jr, Mittleman RS, Profy AT, Seferovic JP, Reasner D, Konstam MA. Rationale and design for a multicenter, randomized, double-blind, placebo-controlled, phase 2 study evaluating the safety and efficacy of the soluble guanylate cyclase stimulator praliciguat over 12 weeks in patients with heart failure with preserved ejection fraction (CAPACITY HFpEF). Am Heart J. 2020 Apr;222:183-190. doi: 10.1016/j.ahj.2020.01.009. Epub 2020 Jan 21.
Individual participant dataSharing planned: No

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
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Recruiting
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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.

Jelena Seferovic, MD PhD study director

Cyclerion Therapeutics, Inc.

62 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IW-1973 in people with Heart Failure With Preserved Ejection Fraction, run by Akebia Therapeutics at 62 sites in 2 countries.

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 13 inclusion and 12 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Study Drug-related TEAEs (time frame: Day 1 up to Day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03254485, which also lists 2 linked publications.

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 15 Sep 2022.