Heart FailurePhase 2Cycle-2-PEFNCT06215586
Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Preserved Ejection Fraction (Cycle-2-PEF)
A Phase 2 study testing Tovinontrine (CRD-750) in people with Heart Failure and Heart Failure Preserved Ejection Fraction, run by Cardurion Pharmaceuticals, Inc. at 84 sites in 15 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with preserved ejection fraction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure Preserved Ejection Fraction, Cardiovascular Diseases
- What is being tested?
- Tovinontrine (CRD-750)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 84 sitesin 15 countries
- Study dates
- 13 Feb 2024to 2 Sep 2025
- Phase
- Phase 2
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
- Is an adult male or female patient ≥ 18 years of age
- Has evidence in the medical history supporting a diagnosis of clinical HF syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening. The HF syndrome is defined by documentation of 1 or more of the following:
- At least 1 of the typical symptoms due to HF such as dyspnea and/or fatigue limiting exercise capacity;
- At least 1 of the typical signs of HF such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or
- Hospitalization, emergency department visit, or outpatient visit for HF requiring intravenous (IV) or subcutaneous (SQ) diuresis within the past 12 months.
- Has ejection fraction (EF) >40% and left atrial enlargement by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;
- Has NT-proBNP level ≥ 300 pg/mL at the time of Screening. Patients with atrial fibrillation or flutter at the time of Screening are required to have an NT proBNP level of ≥500 pg/mL at the time of Screening;
- Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgment, for a minimum of 4 weeks prior to the time of Screening and during the Screening Period, with no planned changes after randomization; Has had no addition of new guideline-directed HF therapy within the 3 months prior to the time of Screening or during the Screening Period;
Who cannot join
- Has documented EF ≥ 60% by TTE within 6 months of the time of Screening or during the Screening Period;
- Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 60 days of the time of Screening or during the Screening Period;
- Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration;
- Has elective interventions (eg, percutaneous coronary intervention, device implantations, percutaneous structural heart disease interventions, cardiac and non-cardiac surgery) planned to occur during involvement in this study;
- Has acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, or carotid angioplasty within 60 days of the time of Screening or during the Screening Period;
- Has had a prior or planned orthotopic heart transplantation;
- Has presence of or plan for mechanical circulatory support;
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
84 sites in 15 countries.
84 sites in 15 countries
United States22 sites
Cardurion Investigative Site
Alexandria, Louisiana, 71301
Cardurion Investigative Site
Birmingham, Alabama, 35233
Cardurion Investigative Site
Buffalo, New York, 14215
Cardurion Investigative Site
Burlington, Vermont, 05401
Cardurion Investigative Site
Cleveland, Ohio, 44195
Cardurion Investigative Site
Covington, Louisiana, 70433
Cardurion Investigative Site
Dallas, Texas, 75246
Cardurion Investigative Site
Hazel Crest, Illinois, 60429
Cardurion Investigative Site
Jacksonville, Florida, 32216
Cardurion Investigative Site
Little Rock, Arkansas, 72204
Cardurion Investigative Site
McKinney, Texas, 75069
Cardurion Investigative Site
Miami, Florida, 33137
Cardurion Investigative Site
Nashville, Tennessee, 37232-7601
Cardurion Investigative Site
New York, New York, 10019
Cardurion Investigative Site
Oklahoma City, Oklahoma, 73135
Cardurion Investigative Site
Orange, California, 92868
Cardurion Investigative Site
Peoria, Illinois, 61636
Cardurion Investigative Site
Portland, Oregon, 97225
Cardurion Investigative Site
Rapid City, South Dakota, 57701
Cardurion Investigative Site
St Louis, Missouri, 63110
Cardurion Investigative Site
Torrance, California, 90502
Cardurion Investigative Site
Van Nuys, California, 91405
United Kingdom9 sites
Cardurion Investigative Site
Bridgend, CF31 1RQ
Cardurion Investigative Site
Chichester, PO19 6SE
Cardurion Investigative Site
Dundee, DD1 9SY
Cardurion Investigative Site
Glasgow, G81 4DY
Cardurion Investigative Site
Harrow, HA1 3UJ
Cardurion Investigative Site
Isleworth, TW7 6AF
Cardurion Investigative Site
London, SE5 9RS
Cardurion Investigative Site
London, W1T 7HA
Cardurion Investigative Site
Southampton, SO16 6YD
Poland8 sites
Cardurion Investigative Site
Grodzisk Mazowiecki, 05-825
Cardurion Investigative Site
Lodz, 92-213
Cardurion Investigative Site
Lublin, 20-011
Cardurion Investigative Site
Sopot, 81-717
Cardurion Investigative Site
Torun, 87-100
Cardurion Investigative Site
Warsaw
Cardurion Investigative Site
Wroclaw, 50-556
Cardurion Investigative Site
Wroclaw, 50-981
Bulgaria7 sites
Cardurion Investigative Site
Burgas, 8008
Cardurion Investigative Site
Gabrovo, 5300
Cardurion Investigative Site
Plovdiv, 4002
Cardurion Investigative Site
Plovdiv, 4003
Cardurion Investigative Site
Rousse, 7000
Cardurion Investigative Site
Sofia, 1000
Cardurion Investigative Site
Stara Zagora, 6000
Canada6 sites
Cardurion Investigative Site
Cambridge, Ontario, N1R 6V6
Cardurion Investigative Site
Chicoutimi, Quebec, G7H 7K9
Cardurion Investigative Site
Hamilton, Ontario, L8L 2X2
Cardurion Investigative Site
Montreal, Quebec
Cardurion Investigative Site
Sherbrooke, Quebec, J1G 2E8
Cardurion Investigative Site
Trois-Rivières, Quebec, G8Z 3R9
Germany5 sites
Cardurion Investigative Site
Brandenburg, State of Berlin, 10787
Cardurion Investigational Site
Dresden, 01067
Cardurion Investigative Site
Elsterwerda, Brandenburg, 04910
Cardurion Investigative Site
Magdeburg, 39120
Cardurion Investigative Site
Papenburg, Lower Saxony, 26871
Hungary5 sites
Cardurion Investigative Site
Balatonfüred, 8230
Cardurion Investigative Site
Budapest, H-1122
Cardurion Investigative Site
Gyöngyös, 3200
Cardurion Investigative Site
Hatvan, 3000
Cardurion Investigative Site
Orosháza, 5900
Netherlands5 sites
Cardurion Investigative Site
Eindhoven, 5504 DL
Cardurion Investigative Site
Groningen, 9713 AP
Cardurion Investigative Site
Hardenberg, 7772 SE
Cardurion Investigative Site
Sneek, 8601 ZR
Cardurion Investigative Site
Zutphen, 7207 AE
Spain5 sites
Cardurion Investigative Site
Córdoba, 14004
Cardurion Investigative Site
Málaga, 29010
Cardurion Investigative Site
Santiago de Compostela, 15706
Cardurion Investigative Site
Seville, 41009
Cardurion Investigative Site
Valencia, 46026
Taiwan4 sites
Cardurion Investigative Site
Kaohsiung City
Cardurion Investigative Site
Taipei
Cardurion Investigative Site
Taipei County
Cardurion Investigative Site
Taoyuan
Czechia3 sites
Cardurion Investigative Site
Hradec Králové, 500 02
Cardurion Investigative Site
Hradec Králové, 50005
Cardurion Investigative Site
Prague, 128 02
Belgium2 sites
Cardurion Investigative Site
Bruges, 8000
Cardurion Investigative Site
Sint-Niklaas, 9100
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with preserved ejection fraction
- Conditions
- Heart Failure, Heart Failure Preserved Ejection Fraction, Cardiovascular Diseases, Heart Diseases
- Being tested
- Tovinontrine (CRD-750), Placebo
- Keywords
- PDE9, PED9 Inhibitor, Heart Failure, CRD-750, Tovinontrine, HFpEF
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tovinontrine (CRD-750)Drug
Also called IMR-687
Tablet administered orally
PlaceboDrug
Tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Tovinontrine (CRD-750) | Experimental | Experimental: Tovinontrine (CRD-750) Receives: Drug: Tovinontrine (CRD-750) |
| Placebo | Placebo comparator | Placebo Comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers from Baseline to Week 12 - NT-proBNP
The percent change in plasma NT-proBNP from Baseline to Week 12.
Measured: Baseline to Week 12
Secondary outcomes (8)
Change in biomarkers at week 12 by treatment group - cGMP
The percent change in urine and plasma cGMP from Baseline to Week 12.
Measured: Baseline to Week 12
Change in biomarkers at week 12 by treatment group - BNP
The percent change in BNP from Baseline to Week 12.
Measured: Baseline to Week 12
Change in the biomarker ratio at Week 12 - NT-proBNP
The percent change in the urine and plasma cGMP to NT-proBNP ratio at week 12.
Measured: Baseline to Week 12
Change in the biomarker ratio at Week 12 - BNP
The percent change in the urine and plasma cGMP to BNP ratio from Baseline to Week 12.
Measured: Baseline to Week 12
The change from baseline in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
Scaled 0 to 100 where lower scores represent worse health status than higher scores
Measured: Baseline to Week 12
The change from baseline in the KCCQ-23-CSS
The proportion of patients with a ≥5, 10, and 20-point improvement in the KCCQ-23-CSS at Week 12
Measured: Baseline to Week 12
New York Heart Association (NYHA) classification at Week 12
The post-baseline NYHA classification at Week 12
Measured: Week 12
Treatment Emergent Adverse Events (TEAEs)
The number of participants with TEAEs including drug related AEs, serious AEs (SAEs), and AEs leading to study drug discontinuation.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start13 Feb 2024
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brandon Atkins, Study director, VP Head, Clinical Development Cardurion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215586
- Sponsor's protocol ID
- CRD-750-202
- Other IDs
- 2023-508737-13, 2023
- Acronym
- Cycle-2-PEF
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No